"Broad spectrum" tumor immunotherapy! The application for the second unlimited cancer species in Mercadon Keytruda is reviewed by the FDA!

April 08, 2020 /
prnewswire
BIOON/ -- Merck and Co recently announced that the U.S Food and Drug Administration (
FDA ) has accepted and granted priority review to a supplemental biological product license application (BLA) for anti-PD-1 therapy Keytruda (Corrida, generic name: pembrolizumab, Pablo zumab) The BLA seeks to expedite the approval of Keytruda as a single-drug therapy for adult and child treatment of non-surgically rectructable or metastatic solid tumors that are not associated with tumor type based on a biomarker , specifically: a test approved by the FDA identified as tissue tumor mutation load (TMB-H) of 10 mutations/megabases, advanced after prior treatment and no replacement of the treatment of non-satisfactory metastatic metastatic FDA has set a target date for the BLA's Prescription Drug User ChargeS (PDUFA) date of June 16, 2020 "Biomarker research has been a key aspect of our clinical approach to evaluating Keytruda monotherapy," said Dr Scott Ebbinghau, Vice President of Clinical Research at the Mercadon Research Laboratory TMB has been an area of scientific concern to help identify patients most likely to benefit from Keytruda treatment We look forward to working with FDA throughout the review to help introduce Keytruda monodotherapy to cancer patients in second- or multi-line therapy environments, where options remain limited "
this BLA is based in part on the results of the Phase II KEYNOTE-158 trial (NCT02628067), which also supports a FDA approved by Mersadon in 2017: Keytruda as the first anticancer drug based on a biomarker that is not related to the type of cancer, specifically for the treatment of microsatellite instability (MSI-H) or the wrong type of cancer treated (dMR) MSI-H is located at the highest end of the TMB lineage Data from the group of Patients with TMB-H in the KEYNOTE-158 study were presented at the European Society of Oncology (ESMO) 2019 Keytruda is a PD-(L)1 tumor immunotherapy that helps detect and fight tumor cells by improving the body's immune system Keytruda is a human-derived monoclonal antibody that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, activating T lymphocytes that may affect tumor cells and healthy cells so far, several PD-1
1-
oncology immunotherapy have been approved worldwide, with Keytruda being the leader in the field, with more than 20 therapeutic indications approved, and global sales reaching $11.1 billion in 2019, up 58% from the previous year with the largest clinical development of immuno-oncology in the industry, Mersadon, there are more than 1,000 clinical trials investigating Keytruda's role in multiple types of tumor and treatment background The Keytruda Clinical Project aims to understand the role of the drug in cancer and the factors that may predict patients will benefit from Keytruda treatment, including exploring several different biomarker notably, earlier this month, Mercadon published positive data for evaluating keytruda first-line treatment for high microsatellite instability (MSI-H) or mismatch repair defects (dMMR), non-reprecentable or metastatic colorectal cancer (mCRC) patients stage III KEYNOTE-177 (NCT02563002) The results showed that the study reached one of the two main endpoints of the non-progressive survival (PFS) a mid-term analysis conducted by the Independent Data Monitoring Committee (DMC) found that in this patient population, Keytruda monotherapy achieved a statistically significant and clinically significant improvement in PFS compared to chemotherapy (mFOLFOX or FOLFIRI, combined or not associated with bebamaror monoantigen or citoshiproanoids selected by the researchers) In accordance with the DMC's recommendations, the study will continue without any changes to assess the total lifetime (OS) of one of the two main endpoints In this experiment, Keytruda's safety was consistent with previously reported studies and no new safety signals were found based on the above results, KEYNOTE-117 is the first head-to-head phase III trial that compares single anticancer drugs with standard nursing chemotherapy for first-line treatment of MSI-H or dMMR colorectal cancer The research data will be presented at the upcoming Medical Conference and will be shared with regulators around the world (BioValleyBioon.com) original origin: Merck Receive Review from FDA for Second app
lication for KEYTRUDA ® (pembrozumab) Baed on Biomarker, Arle of Tumor Type