Tdm1 ema approval


tdm1 ema approval TUKYSA (tucatinib) is the first HER-2 tyrosine kinase inhibitor approved in European Medicines Agency (EMA) validated the marketing authorisation with either trastuzumab/pertuzumab or ado-trastuzumab emtansine (T-DM1) and a  3 Dec 2017 (FDA) and the European Medicines Agency (EMA) approved the clinical use of T- DM1, which was the first ADC that was specifi-. Just wondering if anyone else is on tdm1 what side effects do you get and does your body adjust to the meds or am I going to sleep Oct 27, 2012 · Roche said its Genentech unit will soon submit a marketing application to the European Medicines Agency for trastuzumab emtansine (T-DM1) and has already applied for a license with the U. The European Medicines Agency (EMA) limited the approval to patients with Lapatinib, pertuzumab and T-DM1 are all HER2-directed agents approved for  drugs approved by the U. Therefore, the purpose of this article was to compare and contrast product labeling claims for new drug entities or biologic license agents approved by the FDA and the EMA in the years 2006 through 2010. For example, trastuzumab was approved in the USA in 1998 (24), but was only available and reimbursed by the SUS in 2012, although only in the adjuvant setting (25). Genentech 에서 개발되고 있던 항암제 T-DM1이 지난 2월 22일 금요일에 드디어 FDA 승인을 받았습니다. Based on the EMILIA findings, Roche and Genentech plan to submit applications for trastuzumab emtansine in HER2-positive mBC this year to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA). Since the approval of the first HER2-targeted therapy, trastuzumab, other anti-HER2 targeted agents have been developed and tested in the metastatic and in the (neo)adjuvant settings, including lapatinib, pertuzumab, neratinib and TDM1 . Aug 27, 2012 · Separately, the marketing application for trastuzumab emtansine has been submitted to the US FDA, and one is to be submitted shortly to the European Medicines Agency (EMA). sgml : 20190801 20190801141019 accession number: 0001104659-19-043291 conformed submission type: 6-k public document count: 12 conformed period of report: 20190801 filed as of date: 20190801 date as of change: 20190801 filer: company data: company conformed name: genetic technologies ltd central index key: 0001166272 standard Oct 13, 2019 · The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU) whose goal is to promote and protect human and animal health. Trastuzumab emtansine (T-DM1) is a novel antibody-drug conjugate, which is   23 Oct 2019 Apr 20 · Approved in US [12]. Gettinger – JCO 2018 * Vokes – Ann Oncol 2018 * Eberhardt – J Thorac Oncol 2015 four ADCs are FDA-approved for clinical usage in certain lym-phomas (brentuximab vedotin), acute lymphoblastic leukemia (inotuzumab ozogamicin), acute myeloid leukemia (gemtuzu-mab ozogamicin) or HER2þ breast cancers (trastuzumab emtan-sine/T-DM1). 2-100-300-w1-000 ( discontinued by manufacturer, servo controller, 300 vdc bus, 100 amp, ac servo, tdm series, internal fan ) parts. It is a bit of a minefield unfortunately :-( There are a lot of cancer patients whose type of cancer has hardly any funding at all, the evil Pancreatic cancer comes to mind but there are lots of others - Some even begrudge the amount of cash that has been thrown at breast cancer considering the wide range of treatment regimes BC patients can now have. November 20, 2013 Trastuzumab emtansine (Kadcyla, Roche/ImmunoGen) has now been approved in Europe for use in the treatment of HER2 -positive metastatic breast cancer, following a positive opinion approved its use based on the pivotal EMILIA clinical trial. KADCYLA is a prescription medicine used to treat  Phase III/LCM Projects: refers to assets that are pivotal in Phase II/III, or that have been submitted for regulatory approval, and may include assets that are now  26 Apr 2019 It should be noted that 'similar biologics' approved in India might not have The EMA (European Medicines Agency) regulatory requirements  19 Apr 2020, FDA and EMA Accept Applications for Genentech's Ocrevus 23 Mar 2020, Genentech Announces FDA Approval of Clinical Trial for Actemra to  12 May 2020 Seattle Genetics Announces the Approval of TUKYSA™ (tucatinib) in trastuzumab, pertuzumab and trastuzumab-emtansine (T–DM1). Much of the  10 Aug 2020 and European Medicines Agency (EMA) have approved record numbers Addition of Capecitabine to T-DM1 in Previously Treated Patients  30 Jun 2016 Recently, T-DM1 has been approved by the European Medicines Agency (EMA) and by the Food and Drug Administration (FDA), as a single  19 Mar 2014 To compare the efficacy of T-DM1 to the approved combination of lapatinib and capecitabine in terms In accordance with the FDA and EMA. T-DM1 is approved for use in patients with HER2-positive metastatic breast cancer who previously received treatment with trastuzumab and a taxane. Herceptin is approved by the FDA to treat advanced-stage, HER2-positive breast cancers and to lower the risk of recurrence of early-stage, HER2-positive (FDA) and the European Medicines Agency (EMA) approved the clinical use of T-DM1, which was the first ADC that was specifi-cally developed for the treatment of HER2-positive BC. (Euronext Amsterdam: PHARM) today announced it has received European Medicines Agency (EMA) approval of a Type II Variation for a new production facility for the PRS-060’s Potency is Similar to that of Dupilumab PRS-060 reduces levels of pSTAT6, eotaxin-3, TARC and MDC in a comparable manner to dupilumab IC [nM] IC [nM] IC [nM] IC [nM] Drug 50 50 50 50 pSTAT6 Eotaxin-3 TARC MDC PRS-060 1. Considering that osimertinib can lead to enhanced HER-2 expression on cell surface and HER-2 overexpression is a mechanism of resistance to osimertinib, this study was addressed to investigate the potential of combining osimertinib with trastuzumab emtansine (T-DM1) in order to improve EMA Scientific Guidelines Have Set Detailed Approval Standards for Biosimilars. • European Medicines Agency Recommends Several Approvals serious adverse events on the trial (3 with trastuzumab, 2 with T-DM1), from which all. DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03] - Full Text View. Six medicines have taken a big step towards European approval having been recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use. Another phase III study, TH3RESA, ran-domised pretreated patients to TDM1 or treatment by investigator’s choice. 10 Trastuzumab emtansine (T-DM1) is an antibody−drug conjugate that combines trastuzumab with DM1, a cytotoxic agent that induces cell death by inhibiting microtubule polymerization. A diagnosis of celiac disease is made based on clinical, genetic, serologic, and duodenal morphology features. Dec 01, 2019 · The second-generation representative drug is ado-trastuzumab emtansine (T-DM1), which has been approved by the FDA to treat human epidermal growth factor receptor-2 (HER2)+ metastatic breast cancer and to improve patient prognosis [ 9 ]. EMA approves Trastuzumab for treatment of HER2+ mGC TDM1 Enters clinical Trials 2015 Possible Biosimilar entry 2001 Pertuzumab and TDM1 approvals Example: Her 2 buy new or surplus bosch tdm1. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. Its tolerance profile is good; the main side effects concern the gastrointestinal system (diarrhea) and dermatologic symptoms. In the SUS, access to innovative and high-cost drugs is low, and, in general, it is lagging many years behind in relation to the date of drug approval in developed countries. The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), has recommended the approval of Lynparza (olaparib) tablets for the treatment of Jan 28, 2016 · The EMA’s approval of Samsung Bioepis’s Benepali is, arguably, a more significant event for European rheumatologists and European payers than the approval of biosimilar infliximab in 2013. All patients had locally advanced breast cancer with at least one of the following features at presentation: T3, T4, N2, and N3. 6 May 2019 On May 3, 2019, the Food and Drug Administration approved ado-trastuzumab emtansine (KADCYLA®, Genentech, Inc. Oct 01, 2015 · Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication. Food and Drug Administration (FDA) this year for the Roche receives FDA approval for cobas HPV test for use on the cobas 6800/8800 Systems to identify women at risk for cervical cancer more Published on: 20 April 2020 TDM1 Acetaminophen Amikacin Carbamazepine Digoxin Gentamicin Lidocaine N-Acetylprocainamide Phenobarbital Phenytoin Primidone Procainamide Quinidine Salicylate Theophylline Tobramycin Valproic Acid Vancomycin URINE CHEMISTRIES UC1 Chloride Ethyl Alcohol Glucose Potassium Sodium Total Protein Urea Nitrogen Uric Acid UC4 Calcium Creatinine Actions against cancer are coordinated by the National Cancer Control Program, created in 2005, which prioritizes cancer prevention and appropriate and timely access to diagnosis and treatment, as well as access to palliative care. 2 Approved Indication TUKYSA in combination with trastuzumab and capecitabine is indicated for the treatment of patients with metastatic HER2-positive breast cancer, who have previously received 2 or more anti-HER2 regimens in any setting, including trastuzumab, pertuzumab and trastuzumabemtansine (T- –DM1) (see “Clinical Efficacy”). Many HER2 positive breast cancers eventually advance to the point where no currently approved HER2 targeting therapy continues to control the disease, and there is no established standard of care after treatment with trastuzumab, pertuzumab and T-DM1. ThisIsBasketball - your home for basketball news, blogs, videos, podcast and everything you love about the game. With the commercial success and approval of several PARP inhibitors by the FDA and EMA, the interest in this topic has decreased. T-DM1 is an innovative systemic treatment that combines the targeting properties of antibodies to deliver a highly potent anticancer agent directly to the neoplasm, thus minimising the damage to nearby healthy cells. This is for all the currently authorized DARZALEX intravenous formulation application in relapsed/refractory and frontline TDM1 Activity in CNS • TDM1 approved 2013 for HER2+ MBC • Patients with active brain mets excluded from all trials • Single case report, followed by, • 10 pt case series: • 3PR, 2SD>6 mo • Median intracranial PFS 5 mo • median OS not reached • 39 pt case series: • 17 PR • Median PFS 6. Food and Drug Administration (FDA) to treat HER2-positive, metastatic breast cancer that has previously been treated with Herceptin and a taxane chemotherapy. FDA Approved: Yes (First approved February 22, 2013) Brand name: Kadcyla Generic name: ado-trastuzumab emtansine Dosage form: Injection Company: Genentech, Inc. Feb 20 · The EMA has validated the MAA for tucatinib in combination with trastuzumab and previously treated with trastuzumab, pertuzumab and T-DM1 - with capecitabine and trastuzumab. The present invention relates to the duocarmycin-containing antibody-drug conjugate (ADC) trastuzumab vc-seco-DUBA (SYD985) for use in the treatment of trastuzumab emtansine (T-DM1) refractory HER2 IHC 3+ or HER2 IHC 2+/FISH positive cancer patients, particularly T-DM1 refractory breast cancer patients. To date, BC can benefit from different therapeutic strategies involving surgery, ablation, chemotherapy, radiotherapy, and more specific approaches such as Acknowledgment for Continuing Education (P. T-DM1 has been approved for use in patients with MBC who have failed prior therapy with trastuzumab and a taxane. Pentru o mai bună înţelegere a tipurilor de terapii, a indicaţiilor, cât şi a efectelor FcRγIIb appears to play a role in nonspecific uptake as preincubation with an anti-CD32 mAb decreased internalization of Alexa488conjugated T-DM1 by approximately twofold. Drug and regimen monographs and information sheets for patients provide information on dosing and administering cancer treatment protocols. Sep 30, 2013 · Methods: This open-label single centre trial was approved by the Calgary Conjoint Health and Research Ethics Board and Health Canada. It is used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in adults who previously received trastuzumab and a taxane (type of cancer medicine). 5 credit online course includes examples from current laboratory best practices and offers real-world, tangible knowledge that can be immediately applied in your laboratory. 2-100-300-W1 TDM1 US/EU MBC 1981 1985 1987 1990 1992 1998 2000 2005 2007 2012 2013 Milestones in the treatment of HER2+ BC Human HER2 gene cloned HER2 association with poor clinical outcome muMAB 54D Adjuvant Neoadjuvant Pertuzumab Trastuzumab US approved Trastuzumab EU approved Phase I rhuMab HER2 trastuzumab approval Pertuzumab Lapatinib US/EU T-DM1 was approved by the FDA on 3rd May 2019 for the same indication as TGA. The European Medicines Agency has waived the obligation to submit the results of studies with Faslodex in all subsets of the paediatric population in breast cancer (see section 4. In addition, Genentech plans to submit a Biologics License Application for trastuzumab emtansine to the U. See full prescribing information for complete boxed warning Do not substitute KADCYLA for or with trastuzumab. Oct 11, 2019 · It has been approved for the treatment of advanced head and neck cancer in China and other countries except USA . On 4 May 2020, the European Medicines Agency (EMA) issued a guidance to support development and regulatory approval for treatments and vaccines for COVID-19 with the involvement of the dedicated EMA Pandemic Task Force (COVID-ETF). May 14, 2020 · The European Medicines Agency, in communication with 33 developers, was doing all it could to speed up the approval process, the EMA’s head of vaccines, Marco Cavaleri, said, but he was Jul 19, 2019 · Janssen Seeks EMA Approval for Novel Subcutaneous Formulation of DARZALEX® (daratumumab) Data supporting the application demonstrated that the investigational subcutaneous formulation improved Jun 16, 2020 · Halozyme Therapeutics Inc. lapatinib, pertuzumab, and T-DM1 – have earned regulatory approval based on EMA approval of gefitinib in June 2009 for EGFR-positive NSCLC, the French  Trastuzumab emtansina (T-DM1) is an antibody-drug conju- EMILIA trial versus lapatinib plus capecitabine T-DM1 shows an It was approved by EMA. AREAS COVERED: The monoclonal antibodies trastuzumab and pertuzumab, the tyrosine kinase inhibitor lapatinib and the antibody-drug conjugate trastuzmab emtansine are approved for HER2 positive breast cancer. In both rats and cynomolgus monkeys, CL TDM1 was twice as fast as CL TT indicating a 50% shorter terminal t 1/2 for T-DM1 versus TT. Jun 01, 2015 · By Julie Steenhuysen CHICAGO (Reuters) - The National Cancer Institute in July will start enrolling patients in a clinical trial seeking to match the underlying genetic defect driving a person's tumour with one or more of 20 approved or experimental drugs targeting that gene. In a first attempt, we tested the cardiotoxic effects of pertuzumab and TDM1 on H9C2 and HFC cells in vitro by using trastuzumab and doxorubicin as controls. AZD1402/PRS-060, an inhaled Anticalin® IL4-Rα antagonist, potently inhibits IL-4 induced g approval. T-DM1 significantly reduces toxicity to healthy Jan 03, 2013 · One note: Mylotarg was removed from the market in 2010 after newer studies showed it did not prolong lives and had safety problems. , a biopharmaceutical company that develops anticancer products using its Targeted Antibody Payload technology and antibody expertise, today announced that Aug 19, 2020 · The findings supported the accelerated approval of rucaparib for the treatment of men with metastatic castration-resistant prostate cancer who have a deleterious BRCA mutation and who have previously received androgen receptor-directed therapy and taxane-based chemotherapy. Transition Networks advances data networks by providing built-to-perform network integration solutions that optimize existing network infrastructures. (NASDAQ:HALO) has announced that Janssen-Cilag International has received marketing approval from the European Commission for DARZALEX (daratumumab) which is a subcutaneous formulation for the treatment of multiple myeloma in adult patients. Mar 28, 2015 · Kadcyla was officially approved and made available to patients in France without being part of clinical trials. FEATURES 8 16 Fox fights bone marrow The Williams major gift cancer and wins advances cancer research Superior Court Judge Carl Fox is “We have faith scientists will back on the bench after a cord unlock mysteries behind this blood transplant saved his life. At initial approval, Mylotarg was associated with a serious liver condition called veno-occlusive disease, which can be fatal. 31 Jan 2020 If approved, tucatinib has the potential to be a clinically meaningful with HER2- positive metastatic breast cancer after progression on T-DM1. Phone : 305-575-6284 CAP approval Health Canada Special Access Request Form A Jan 21, 2020 · Product manufactured at the new facility during the approval process is now available for distribution within the EU Leiden, the Netherlands – 21 January 2020 Pharming Group N. , at the end o een its HoFH ith a half-life carries the e I trials in J ll study, in fe er session d g discussio e late-stage Mipomersen f January 2 product an of 20–30 ho risk of inject apanese pa wer than 10 irectly proce n on Aegerio HoFH cand ’s PDUFA d 013. 25 – 27 The National Institute for Health and Care Excellence (NICE) invited the manufacturer of trastuzumab emtansine (T-DM1) (Kadcyla ® ; Roche) to submit evidence of its clinical and cost-effectiveness for treating human epidermal growth factor receptor 2 (HER2)-positive, unresectable, locally advanced or metastatic breast cancer after treatment with trastuzumab and a taxane. 1 mo Oct 08, 2018 · Novartis announces FDA and EMA filing acceptance of siponimod, the first and only drug shown to meaningfully delay disability progression in typical SPMS patients Oct 08, 2018 There is a critical need for safe and effective treatments for secondary progressive multiple sclerosis (SPMS) - a highly debilitating form of MS characterized by gradual Trastuzumab-emtansine (TDM1) VEGF (vascular endothelial growth factor) Targeting VEGF. [11] [12] [13] Trastuzumab emtansine was developed by Genentech , a subsidiary group of Roche , and is manufactured by Lonza . Can I use TDMI (or, perhaps Pertuzumab) for my gastric cancer patient? Afterall, these are drugs where the safety The primary objective of this study is to evaluate the efficacy, as measured by progression-free survival (PFS) assessed by independent review and overall survival (OS), of margetuximab plus chemotherapy compared with trastuzumab plus chemotherapy in patients with advanced HER2+ breast cancer who have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting, or 0001104659-19-043291. Prior treatment could have T-DM1 is an antibody-drug conjugate approved for management of HER2-positive metastatic breast cancer. HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk) is approved for the treatment of adults with early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. 31 Aug 2019 To date, five ADCs have received market approval and over 100 are being In 2013, the FDA and EMA approved T-DM1 as a monotherapy for  EMA gives trastuzumab biosimilar Marketing Authorisation Application. 5×10-7 to 1,000 Torr) Ultra-wide range and high performance best-in-class MEMS Pirani sensor Precision gas independent di Lapatinib is a synthetic, orally-active quinazoline with potential antineoplastic properties. GenentechMedia Contact:Susan Willson, 650-467-6800Advocacy Contact The clinically approved T-DM1 (Kadcyla®) is an antibody-drug conjugate consisting of HER2-targeting trastuzumab linked to the potent MDA and maytansine derivative DM1. • Melanoma Trastuzumab etmansine (T-DM1)  25 Feb 2020 T-DM1 received US Food and Drug Administration (FDA) approval in February 2013 [11] and European Medicines Agency (EMA) marketing  (SmPC) and available drug approval reviews, as published by EMA and FDA. The EMA does so by the use of medications in Nov 04, 2015 · Tumour type Biomarker Drug Breast cancer HER-2 overexpression Trastuzumab1 , lapatinib2 , pertuzumab, TDM1 Gastric cancer HER-2 overexpression Trastuzumab1 CML BCR/ABL fusion gene Imatinib3 GIST c-KIT mutation Imatinib3 NSCLC EGFR mutation Gefitinib4 , erlotinib5 mCRC RAS gene mutation status Panitumumab6 , cetuximab7 Melanoma BRAF V600 Find out about different cancer treatments and drugs, and get help with treatment decisions you might need to make. This includes access to high‐cost medications such as trastuzumab, pertuzumab, and TDM1 for breast cancer. Trastuzumab-DM1 (TDM1), a novel anti-ErbB2 antibody–drug conjugate approved by the FDA for the therapy of breast cancer patients resistant to trastuzumab, 24 is made up of trastuzumab and emtansine (DM1), a highly potent antimicrotubule agent, which binds to tubulin and inhibits microtubule assembly with greater potency than vincristine or vinblastine. The approval is based on results from the pivotal trial HER2CLIMB, a randomized (2:1), double-blind, placebo-controlled trial that enrolled 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1). They are for general reference and are not meant to replace prescribing information or physician recommendations. The results were positive, indicating an 18 percent reduction of traffic in the congestion charge zone (equivalent to 96,000 vehicles per day). Includes some oversight about drug safety by the FDA and the treatment center’s institutional review board (IRB) Yes. ado-trastuzumab emtansine (FDA approved generic name) trastuzumab emtansine (EMA international non-proprietary name (INN) name) Kadcyla ® (Current brand of trastuzumab emtansine in Europe and the States) TDM1 was the term used to describe trastuzumab emtansine in clinical trials Evidence of Harm Oct 04, 2018 · The drug was also approved in 2013 in Japan by the MHLW (Ministry of Health, Labour and Welfare) and in Europe by the EMA. In a Phase II trial (HER2CLIMB) that supported FDA approval, addition of Tukysa (tucatinib) to Herceptin (trastuzumab) and Xeloda (capecitabine) significantly improved progression-free survival at 1 year (PFS1) compared to placebo (33. Sep 23, 2019 · HER2 is an established therapeutic target in a large subset of women with breast cancer; a variety of agents including trastuzumab, pertuzumab, lapatinib, neratinib and trastuzumab emtansine (T 5y . When the antibody binds to HER2, the cell internalises the antigen-antibody complex; consequently, trastuzumab is degraded in the lysosome and DM1 is set free within the cancer cell. Have discontinued all previous therapies for cancer (except trastuzumab) for at least 21 days for myelosuppressive agents or 14 days for non-myelosupprevice agents 8. Oct 01, 2012 · BackgroundTrastuzumab emtansine (T-DM1) is an antibody–drug conjugate incorporating the human epidermal growth factor receptor 2 (HER2)–targeted antitumor properties of trastuzumab with the Trastuzumab was approved for medical use in the United States in September 1998, and in the European Union in August 2000. Aug 14, 2020 · An Insiders Guide to Gaining Product Approvals Across EMEA Having drugs approved by EMEA regulatory bodies is an essential part of providing safe and effective medicines to patients in the region. Sep 27, 2011 · He said that the legal and legislative committee is capable of completing the approval of a number of anti-corruption bills proposed by MPs before the Oct 25 start of the new parliamentary term. Trastuzumab emtansine (T-DM1) is approved for the treatment of human epidermal growth factor receptor 2 (HER2)-positive (HER2+) metastatic breast cancer (BC) and for residual disease after neoadjuvant therapy; however, not all patients benefit. We excluded patients with HER2‐negative disease, those without treatment with anti‐HER2 agents in the first‐line setting, and those who had received first‐line treatment with an anti‐HER2 agent other than trastuzumab (i. “Kadcyla is an antibody-drug conjugate representing a completely new way to treat HER2-positive metastatic breast cancer, and it helped people in the EMILIA study live nearly six months longer,” said Hal Barron, M. Food and Drug Administration (FDA) to treat: HER2-positive metastatic breast cancer that has previously been treated with Herceptin (chemical name: trastuzumab) and taxane chemotherapy Trastuzumab emtansine is an antibody-drug conjugate that contains trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture, Kadcyla Approval History. May 09, 2014 · Authors analyze the differences in the three regulatory agencies: The FDA, European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PDMA), Japan’s regulatory agency. It will include review of new cancer drugs approved and in late stage clinical Nov 06, 2012 · WALTHAM, Mass. Monoclonal antibodies are biological drugs used to treat cancers, certain types of arthritis, lupus, MS, and IBD. In 2013, an impressive array of biosimilars were approved in the EU, including yet another filgrastim and growth hormone, two infliximabs, and follitropin. These agents have been associated with significant clinical benefits including substantial increases both in Learn more about dosing, efficacy, safety, and patient financial info for ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound). •Pertuzumab: approved 6/2012 •TDM1: approved 2/2013 •Neratinib: soon •Afatinib: soon •HSP90 inhibitors: soon too. [14] Trastuzumab emtansine, also known as ado-trastuzumab emtansine or T-DM1, which is marketed by Genentech / Roche under the trade name Kadcyla®, is an antibody-drug conjugate consisting of the humanized monoclonal antibody trastuzumab covalently linked to the cytotoxic agent DM1. ) for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) Dec 19, 2019 · Levi Garraway, MD, PhD The European Commission has approved ado-trastuzumab emtansine (T-DM1; Kadcyla) for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have Jul 08, 2020 · Kadcyla (chemical name: T-DM1 or ado-trastuzumab emtansine) is a targeted therapy approved by the U. , trastuzumab plus lapatinib May 30, 2017 · The profit margin of industry is “astronomical,” she said, adding her own treatment, Roche’s kadcyla or TDM1, is sold between US$ 2. Oct 03, 2014 · T-DM1 was recently approved for the treatment of patients with HER2-positive metastatic breast cancer that has progressed on prior trastuzumab and taxane chemotherapy . 3dunlop ダンロップ veuro ve304 サマータイヤ 205/55r16:タイヤスクエアミツヤノア アクセラ アクセラスポーツ プレマシー【大好評 SMARTPIRANI™ ATM TRANSDUCER FOR LOAD-LOCKS Vacuum pressure transducer with atmospheric switch, digital and analog interface VPM-7 Vacuum pressure transducer Measurement range 1×10-6 to 1,333 mbar (7. 23-06-2017 LONDON, UK (GlobalData), 03 April 2012 - On March 30, 2012, Roche announced the preliminary success of its antibody-drug conjugate T-DM1 (trastuzumab emtansine) in a critical Phase III clinical trial. Jan 28, 2020 · The European Medicines Agency has waived the obligation to submit the results of studies with trastuzumab emtansine in all subsets of the paediatric population in breast cancer (see section 4. HK) and Accord Healthcare Limited (Accord)'s Zercepac®, a biosimilar trastuzumab, for the treatment of certain patients with HER2-positive early breast cancer, HER2-positive metastatic breast cancer and previously untreated HER2-positive metastatic gastric cancer. Pembrolizumab plus trastuzumab was safe and showed activity and durable clinical benefit in patients with PD-L1-positive, trastuzumab-resistant, advanced, HER2-positive breast cancer. It is fair to say that the uptake of biosimilar infliximab has been muted amongst rheumatologists based on the relatively late-line use of the reference Overall, none has demonstrated efficacy to consistently induce clinical remission or mucosal healing compared with placebo. Pede-se aos profissionais de saúde que notifiquem quaisquer suspeitas CAP approval : No longer on back order Diazoxide – SAP (Proglycem ®) Teva Pharmaceuticals Sellerville, PA, USA 18960 . In 2013 and 2014, the European Medicines Agency (EMA) approved the subcutaneous (SC) formulation of trastuzumab (Herceptin®) and rituximab . , Roche’s Chief Recently, T-DM1 has been approved by the European Medicines Agency (EMA) and by the Food and Drug Administration (FDA), as a single agent for the treatment of patients with HER2-positive locally advanced and unresectable or MBC, who have previously received taxane- and trastuzumab-based treatment, separately or in combination . It is not  Reporting suspected adverse reactions after authorisation of the medicinal product The European Medicines Agency has waived the obligation to submit the  19 Dec 2019 The EMA has cleared Kadcyla (ado-trastuzumab emtansine) for the adjuvant or The new approval is based on the KATHERINE trial, which  15 Nov 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for  20 Nov 2013 Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Kadcyla ( trastuzumab emtansine or T-DM1), the latest targeted medicine from  19 Dec 2019 The European Commission has approved ado-trastuzumab emtansine (T-DM1; Kadcyla) for the adjuvant treatment of adult patients with  18 Nov 2019 On 14 November 2019, the European Medicines Agency's (EMA's) The marketing authorisation holder for this medicinal product is Roche  31 Jan 2020 If approved, tucatinib has the potential to be a clinically meaningful trastuzumab, pertuzumab and T-DM1 (ado-trastuzumab emtansine). In addition, providers of systemic chemotherapy services may submit regimens for consideration for inclusion as NCCP approved regimens which will be available for national use on the NCCP website. Approval: 2013 INDICATIONS AND USAGE KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, News FDA approves Perjeta (pertuzumab) for adjuvant treatment of early breast cancer. NERLYNX is a prescription medicine used to treat adults who have early-stage breast cancer, which is HER2+ and has previously been treated with the medicine trastuzumab. Director, Breast Oncology and Clinical Trials Education NCCN Guidelines ® & Clinical Resources NCCN Chemotherapy Order Templates (NCCN Templates ®) . With T-DM1, the company went out on a limb, applying for an accelerated approval based on a single arm study (no control group) in late-stage HER2+ MBC, but at least the investigators I spoke with were not surprised to learn of FDA's decision. The objective of this study was to evaluate the expression of Trop-2 in USC Jun 26, 2020 · Bristol-Myers Squibb (BMY) Announces EMA Approves Reblozyl for Treatment of Transfusion-Dependent Anemia in Adult Patients with Myelodysplastic Syndromes or Beta Thalassemia Article Related Press The coupling of trastuzumab to the cytotoxic drug emtansine (TDM1) has shown significant clinical activity even in trastuzumab-resistant breast cancers . ]) 1833-1916, August 15, 1900, Page 6, Image 6, brought to you by The New York Public Library, Astor, Lenox and Tilden Foundation, and the National Digital Newspaper Program. However, Fcγ receptor blocking experiments did not completely prevent TDM1 uptake by megakaryocytes, demonstrating that there are other nonFcγR mechanisms involved (60). 42–44 In addition, side effects limit the use of these therapies; recently, the European Medicines Agency has imposed restrictions on the use of ciprofloxacin due to disabling or potentially permanent events [EMA/668915 Unless specifically stated Industrial Ferrox Electric is not approved or sanctioned by any manufacturer or trademark listed. tdm1药物治疗转移性乳腺癌疗效明显。t-dm1最近由fda批准用于治疗her2阳性转移性乳腺癌患者,这些患者之前已接受曲妥珠单抗和紫杉类药物 Based on these findings, Roche plans to submit a Marketing Authorisation Application to the European Medicines Agency (EMA) this year for trastuzumab emtansine in HER2-positive mBC. ADVANTAGES Class AA accuracy 4-20 mA programmable current output0-10 VDC programmable voltage output Robust 316 stainless steel design IP67 enclosure for harsh environments Fast response to temperature changes Compact and low mass sensor probe Optional solid-state setpoint relay for process control Dual sensor design T Jun 08, 2020 · If approved, Gilead’s drug, given intravenously, would be the first approved COVID-19 treatment in Europe. 1 Sep 2017 The approved mAbs and antibody-related therapeutics are directed against been performed using radiolabeled FDA- or EMA-approved drugs, such as cancer patients treated with trastuzumab emtansine (T-DM1) (18). News Chugai's Hemlibra receives the world's first regulatory approval from FDA for hemophilia A with inhibitors. Apr 19, 2020 · The EMA is a moving average that places a greater weight and significance on the most recent data points. A biosimilar was approved in the European Union in November 2017, and in the United States in December 2018. KADCYLA is a prescription medicine used to treat HER2-positive breast cancer that has spread to other parts of the body (metastatic breast cancer) after prior treatment with trastuzumab (Herceptin ®) and a taxane. Feb 27, 2019 · Between 2009 and 2012, the EMA approved only three biosimilars, two of which were filgrastim molecules. CL DEC was approximately 50% of CL TDM1 in both rats and cynomolgus monkeys, indicating that the overall T-DM1 deconjugation is similar In a Phase III (NALA) trial that supported FDA approval, combination of Nerlynx (neratinib) and Xeloda (capecitabine) reduced risk of disease progression or death (HR=0. STANDARD • Level 2 evidence • Have existing evidence for response prediction • Based on mechanism of action • Evaluated in CLIA setting • Agilent 44K array (FDA IDE) • Phospho-protein array (CLIA) • DNA mutation panel (CLIA) • Hypothesis testing Oct 13, 2017 · Breast cancer (BC) is a persistent global challenge for its high frequency in women (although it seldom occurs in men), due to the large diffusion of risk factors and gene mutations, and for its peculiar biology and microenvironment. 2 Feb 2018 Subsequently, trastuzumab was approved by the EMA and FDA as and ado- trastuzumab emtansine (T-DM1), is standard treatment for  Patients are selected for therapy based on an FDA-approved test for KADCYLA. Termenul „glonț magic” a fost folosit pentru prima dată de Paul Ehrlich la începutul secolulului XX, când a descris anticorpii care ținteu atât celulele tumorale, cât și agenții microbieni. HER2 overexpression assessed by immunohistochemistry (IHC) is associated with poor prognosis in NSCLC (adenocarcinoma). TDM1 Activity in CNS • TDM1 approved 2013 for HER2+ MBC • Patients with active brain mets excluded from all trials • Single case report, followed by, • 10 pt case series: • 3PR, 2SD>6 mo • Median intracranial PFS 5 mo • median OS not reached • 39 pt case series: • 17 PR • Median PFS 6. Trastuzumab emtansine is a combination of two drugs: Trastuzumab (Herceptin), which belongs to a group of drugs called targeted (biological) therapies. Press Release: Coalition for Affordable T-DM1 Asks the Government to Employ Crown Use Authority to Lower Price of Expensive Cancer Drug. Like all moving averages, this technical indicator is used to produce buy and sell signals Feb 24, 2020 · Both the U. Trastuzumab-emtansine (T-DM1) is an antibody drug conjugate composed of a Lapatinib is a FDA and EMA approved dual tyrosine kinase inhibitor (TKI) of  Fast track FDA & EMA approval of drugs and a plethora of clinical trials provide the Fast-track approvals. Obtained SPA from FDA and review by EMA in February 2013 Performed in patients with HER2+ Metastatic Breast Cancer (MBC) who have been treated with two or more prior treatments (third -line disease) Trial Design PB272 plus Xeloda (capecitabine) versus Tykerb plus Xeloda (N=600, 1:1 randomization) TDM1,pertuzumab,neratinib,BIBW2992,PI3kinaseinhibitors,Akt inhibitors,HSP90inhibitors,amongothers),itistimetoprioritizethe development of new molecularly targeted approaches over the opti-mization of existing cytotoxic agents. European Medicines Agency approval summary: Zaltrap for the treatment of patients with oxaliplatin-resistant metastatic colorectal cancer ESMO Open . Mar 15, 2020 · T-DM1 is a new, unique, and selective antibody drug conjugate approved by the European Medicines Agency (EMA) for the treatment of advanced HER2-positive breast cancer. Sacituzumab govitecan (SG) is a novel antibody-drug-conjugate (ADC) targeting trophoblast cell-surface antigen 2 (Trop-2), a transmembrane-calcium-signal-transducer, to deliver SN-38, the active metabolite of irinotecan. Roche won approval in the US late last week for Kadcyla, its much-anticipated follow-up to breast cancer blockbuster Herceptin. Monitor hepatic function Patients are selected for therapy based on an FDA-approved test for KADCYLA. The ESC noted that the Pre-Sub-Committee-Response (PSCR) stated that the KATHERINE data have been submitted to the EMA with approval expected in November 2019. Trastuzumab emtansine (T-DM1) is a HER2-targeted ADC, composed of trastuzumab, a stable thioether linker, and the potent cytotoxic agent, emtansine (DM1, derivative of maytansine). 2020人気新作!!【7月15日 ホワイトレター 最大21倍】 スマック プレマシー kyoho スマック スフィーダ smack ホイールセット sfida ホイールセット 16インチ 16 x 6. Kadcyla 라는 상품명으로 며칠 내에 출시 될 이 약은 Antibody-drug Conjugate (ADC) 라는 종류의 대표격으로 많은 주목을 받고 있던 약입니다. 1 mo Dec 01, 2013 · To our knowledge, however, a formal comparison of all PRO label claims for products approved by both the FDA and the EMA is yet to be conducted. Nov 14, 2016 · Antibody−drug conjugates aim to minimize toxicity by selectively delivering the cytotoxic agent to tumor cells, thereby minimizing systemic exposure. (TDM1), a novel Among ADC-based prodrugs, three molecules have been approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA): brentuximab vedotin (SGN-35), trastuzumab emtansine Just stated tdm1 all I want to do is sleep. Most women in the world cannot access that medicine, she said, and even in the United Kingdom, the drug is not reimbursed by the health system. Oct 02, 2012 · Genentech’s Trastuzumab Emtansine (T-DM1) Significantly Extended Survival in People With Aggressive Form of Breast Cancer. On 29 July 2016, a new approach to the appraisal and funding of cancer drugs in England began operating. Vemurafenib and dabrafenib in BRAF mutant NSCLC Hyman –NEJM 2015 VE-Basket trial 20 BRAFV600 NSCLC ORR: 42%. T-DM1 is approved by the FDA for the treatment of patients with HER2- positive According to the current plans of the EMA, the Clinical. The company is already studying T-DM1 in combination with pertuzumab (Perjeta), which could potentially eliminate the need for chemotherapy. In addition, the company that has developed T-DM1 submitted the drug to the FDA for approval this week (read full statement here). also considered for EC "Kadcyla has been approved for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received Herceptin(R) (trastuzumab) and a taxane, separately or in combination. Further studies in this breast cancer subtype should focus on a PD-L1-positive population and be done in less heavily pretreated patients. Breast Cancer Now is a UK charity providing world-class research and life-changing care for people affected by breast cancer. Drug conjugates, for example, anti-CD30 antibodies (brentuximab) or anti-CD20 (britumomab–tiuxetan) have been approved by the FDA and the EMA for routine clinical use ( 52 ). EGFR (epidermal growth factor receptor) Cetuximab, gefitinib, Tarceva (erlotinib) PI3K/Akt/mTOR (phosphoinositide 3-kinase/protein kinase B/mammalian target of rapamycin Mar 05, 2015 · The approval of the new immunization schedule follows the EMA’s positive opinion of the vaccine, which was granted in February based on results from a phase 3 clinical trial with 546 infants. Marketing authorization was recommended for treatments of opioid dependence, HIV, breast cancer, among others. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of trastuzumab emtansine (T-DM1; Kadcyla) for the adjuvant treatment of adult patients On May 3, 2019, the Food and Drug Administration approved ado-trastuzumab emtansine (KADCYLA, Genentech, Inc. 22ed (BJT), Roche's HER2-ADC drug Entrastuzumabimtansine (Trastuzumabemtansine, trade name: Kadcyla, TDM1 for short) has been approved for marketing in China, and it is expected to be approved in the near future. Therefor the topic collection will include inhibitors of different pathways involved in cancer like PARP, BRAF, tyrosine kinase/protein kinase/multikinase, aurora kinase, cytokines etc. Side effects are itching, rash, chills, cough and constipation, and may include hepatitis, cancer and congestive heart failure. Pertuzumab HER2 receptor Trastuzumab The HERITAGE data have been submitted to the European Medicines Agency (EMA); the patent for the branded trastuzumab has already expired In the United States, a trastuzumab biosimilar could not be considered for market approval until 2019, when the reference trastuzumab patent expires Kadcyla (ado-trastuzumab) is Roche’s third HER2-targeted mAb, approved by the FDA in February 2013, by the Japanese MHLW in September 2013, and by the EMA in November 2013, for the second-line treatment of metastatic HER2-positive breast cancer. T-DM1, also known as ado-trastuzumab emtansine or Kadcyla®, combines the monoclonal antibody trastuzumab with the cytotoxic mertan- Since TDM1 and pertuzumab have been recently approved by the FDA for clinical use, we decided to verify whether they are less toxic than trastuzumab on cardiac cells in vitro. Traditional neoadjuvant systemic chemotherapy plus dual HER2-targeted blockade (docetaxel, carboplatin, and trastuzumab plus pertuzumab) resulted in significantly more patients achieving a pathological complete response than HER2-targeted chemotherapy plus HER2-targeted blockade (trastuzumab emtansine plus pertuzumab); however, numerically more grade 3–4 and serious adverse events occurred As part of a neoadjuvant regimen, pertuzumab added to trastuzumab plus docetaxel was shown to significantly increase the rate of pathological complete response, which led to its approval by health Feb 22, 2013 · Kadcyla is the first FDA-approved ADC for treating HER2-positive mBC, an aggressive form of the disease. Apr 06, 2019 · L (Cell Signaling Technologies 2764), EMA (Dako M0613), MCL-1 (Ventana SP143) and p63 (Biocare CM163A). As there is no ADC drug officially launched in China, Kadcyla will become the first The medical record was reviewed to obtain data on clinical characteristics, including ethnicity, race, age, clinical stage, treatment regimen, and vital status. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment as single agent of patients with HER2+ MBC who previously received trastuzumab BC Cancer’s mandate covers the full spectrum of cancer care from prevention, screening, diagnosis and treatment, to research and education, to supportive and palliative care. There are currently four approved agents for the treatment of HER2+ metastatic breast cancer, trastuzumab, pertuzumab, TDM1 and lapatinib. I have been researching it thru US medical sites/journals for over a year, following its progress in FR, and thru a connection at Roche, I knew it was to be approved in early 2015. Dec 04, 2017 · Osimertinib is a third-generation EGFR-TKI with a high selective potency against T790M-mutant NSCLC patients. Yes The European Medicines Agency (EMA) protects and promotes human and animal health by evaluating and monitoring medicines within the European Union (EU) and the European Economic Area (EEA). 14b, c), mimicking Osler-Weber-Rendu syndrome [183, 184], with the antibody-drug conjugate ado-trastuzumab emtansine (T-DM-1, FDA-approved for the treatment of HER2+ metastatic breast cancer). INF-β mAbs • Similar, but not identical • Justify any differences These results led to the approval of T-DM1 in 2013 by the U. Based on these data, on June 12, 2012 the FDA approved pertuzumab in combination with trastuzumab and docetaxel for HER2-positive MBC in patients who had not received prior HER2-directed therapy or chemotherapy for metastatic disease. NCCN continues to add to the library of chemotherapy order templates to improve the safe use of drugs and biologics in cancer care. For BCL-2 and BCL-X L IHC assays, human tonsil was used as a positive control and un-related PDX tumor tissue was used as a negative control (incubation with May 08, 2020 · Source By Alexander Roussanov, Lincoln Tsang and Eftychia Sideri . The prevention and treatment of metastatic disease in the central nervous system (CNS), including brain metastases, remains a significant unmet medical need for patients with HER2+ breast cancer. Aegerio d ISIS’s is th urs, wherea ion-site reac tients towar On April 26, 2019, the European Medicines Agency announced that its Committee for Medicinal Products for Human Use (CHMP) had recommended approval for 13 new medicines. Oct 20, 2010 · FDA Approved: Yes (First approved September 25, 1998) An approved Premarket Approval Application (PMA) -- like an approved New Drug Application (NDA) -- is, in effect, a private license granted to the applicant for marketing a particular medical device. Roche has taken a critical step forward in defence of its breast cancer portfolio after saying it will file for approval for a follow-up to its top-selling Herceptin (trastuzumab) product during 2012. Lapatinib reversibly blocks phosphorylation of the epidermal growth factor receptor (EGFR), ErbB2, and the Erk-1 and-2 and AKT kinases; it also inhibits cyclin D protein levels in human tumor cell lines and xenografts. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will review Novartis' applications seeking regulatory approval of ofatumumab, an investigational B-cell Aug 28, 2012 · An early 2013 approval will give Roche time to establish the product before the introduction of trastuzumab biosimilars, expected in Europe in 2014 and in the United States in 2019. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment as single agent of patients with HER2+ MBC who previously received trastuzumab and a taxane, separately or in combination. In 2013, the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved the clinical use of T-DM1, which was the first ADC that was specifically developed for the treatment of HER2-positive BC. In contrast to breast and gastric cancers, in NSCLC HER2 overexpression does not always co-occur with HER2 amplification. 8%, 46/314) compared to lapatinib and capecitabine combination in patients with metastatic ERBB2 (HER2)-positive (amp Lapatinib inhibits the tyrosine kinase activity of HER‐2 and has received approval for use in advanced or metastatic breast cancer patients not responding to trastuzumab, combined with capecitabine chemotherapy . Here, we hypothesized that the heterogeneity in the response seen in patients is partly explained by the levels of human epidermal growth factor The present invention relates to the duocarmycin-containing antibody-drug conjugate (ADC) trastuzumab vc-seco-DUBA (SYD985) for use in the treatment of trastuzumab emtansine (T-DM1) refractory HER2 IHC 3+ or HER2 IHC 2+/FISH positive cancer patients, particularly T-DM1 refractory breast cancer patients. 9 Apr 2020 Three biologic drug entities have been approved using trastuzumab, including 2 53 biosimilars were approved by the EMA, 5 of which are biosimilars of directed antibody-drug-conjugates beyond T-DM1 in breast cancer. (Nasdaq:SGEN) today announced positive pivotal data from the HER2CLIMB trial evaluating tucatinib in patients with HER2-positiv Find many great new & used options and get the best deals for TAC Module For Gen 3 LS Engines Part# TMD1-160E1 at the best online prices at eBay! Free shipping for many products! The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a thumbs up to two new oncology drugs. Since approximately 80% of patients in the control arm received trastuzumab-based therapy, TH3RESA is considered a comparison of TDM1 SHANGHAI, July 29, 2020 /PRNewswire/ -- The European Commission (EC) has approved Shanghai Henlius Biotech, Inc. Recent pediatric guidelines, based largely on retrospective data, propose omitting biopsy analysis for patients with concentrations of IgA against tissue transglutaminase (IgA-TTG) >10-fold the upper limit of normal (ULN) and if further criteria are met. This followed the EMILIA phase III trial, which showed that T-DM1 produced a high percentage of responses and significantly improved PFS and OS compared to standard therapies for advanced HER2-positive breast cancers. The batch includes one orphan medicine, Clovis Oncology UK’s Rubraca (rucaparib), which has been developed for the treatment of relapsed or progressive ovarian cancer. For patients harboring a PDGFRA exon 18 mutation, the Genentech Announces FDA Grants Venclexta ™ (Venetoclax) Accelerated Approval for People with a Hard-To-Treat Type of Chronic Lymphocytic Leukemia: 10 Apr 2016 FDA Grants Priority Review for Genentech’s Cancer Immunotherapy Atezolizumab in Specific Type of Lung Cancer: 14 Mar 2016 Trastuzumab remains a very important drug in breast cancer, despite the approval of a number of other drugs — such as pertuzumab (Perjeta, Genentech) and ado-trastuzumab emtansine (TDM-1, Kadcyla; Chemotherapy Drug Information, Side Effects, Health and Wellness, and Resources for cancer patients and caregivers before, during and after cancer treatment. 001) in patients with metastatic ERBB2 (HER2)-positive breast cancer who received Mar 20, 2019 · EMA’s review committee recommends the approval of Lynparza as a treatment for previously treated HER2-negative breast cancer patients who have mutated BRCA. Growth Hormone • Product-specific non -clinical and clinical requirements • Recommended study designs, post-marketing commitments . The EMA also  29 Jan 2019 Approval was based on results from the randomised, open-label, in a post- marketing commitment with the European Medicines Agency. tdm1 ema approval

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