Tumor immunotherapy upgrade! Mercadon Keytruda's 6-week resubmission of the drug program covers all adult indications!

April 24, 2020 /
Biovalley BIOON/ -- Merck and Co recently announced that it has resubmitted its application for a license for complementary biological products to the U.S Food and Drug Administration (
FDA ) to renew the anti-PD-1 therapy Keytruda (Creida), generic name: pembrolizumab, Pablozumab monoantigen) frequency of administration, included in every six weeks (Q6W) of the administration of the drug program, specifically: every six weeks 400 mg intravenous infusion of medicine, infusion time is not less than 30 minutes this BLA covers all of Keytruda's adult indications, including monotherapy and combination therapy In July 2019, the Q6W program BLA submitted by Mercadon was accepted by the FDA , but the agency issued a full response letter (CRL) in February 2020 Mercadon has submitted a resubmission to address the issues mentioned in the CRL Currently, Keytruda's medication regimen is 200 mg (Q3W, intravenous infusion situ for no less than 30 minutes) every 3 weeks If approved, the Q6W solution will provide patients with a more user-friendly treatment option, with reduced frequency of administration and greater treatment flexibility for patients and oncologists application for the Q6W program, based on pharmacokinetic modeling and simulation data presented at the 2018 ASCO Annual Meeting These data support the approval by the European Commission (EC) on 28 March 2019 of keytruda 400mg Q6W administration for all approved single-drug treatment strains covering five types of tumor , including: non-small cell lung cancer (NSCLC), melanoma , bladder cancer, head and neck cancer, and classic Hodgkin's lymphoma "During the pandemic of the new coronavirus pneumonia (COVID-19), the oncology community is rapidly adjusting cancer care to minimize exposure and make cancer patients as safe as possible," said Dr Roy Bayne, Senior Vice President and Chief Medical Officer, Global Clinical Development, 's Mercadon Research Laboratory Now, more than ever, we believe that it is vital to have a six-week dosing plan for Keytruda We appreciate FDA guidance during the resubmission and look forward to working closely with the FDA as the review continues "
PD-(L)1 tumor immunotherapy is a high-profile type of tumor immunotherapy designed to use the body's own immune system to fight cancer, by blocking the PD-1/PD-L1 signaling pathway to kill cancer cells, with the potential to treat a variety of types of tumor Keytruda is an anti-PD-1 therapy 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, 10 PD-1
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cancer immunotherapy have been approved worldwide: Keytruda (Korida, Target PD-1, Mersadon), Opdivo (Odivo, Target P D-1, BestY Squibb), Tecentriq (Special, generic name: atezolizumab, Atezolizumab, Atezolizumab, Target PD-L1, Roche), Imfinzi (Infyfan, generic name: Durvalumab, Davaliu, Target PD-L1, AstraZeneca ), Bavencio (avelumab, target PD-L1, Pfefi /Merck), Libtayo (cemiplimab, Sanofi/Regen), Tui (Triprei, Target PD-1, Junshi Bio), Dabosu (Avelumab, Target) Erika (Carrelli Pearl, Target PD-1, Hengrui Pharmaceuticals), Baczean (Treli Zhu Single Resistance, Target PD-1, Baiji Shenzhou) of the , eight have been approved in China: Keytruda (Korida), Opdivo (Odivo), Imfinzi (Infyvon), Tecentriq (Teshenqi), Bacsaan (Treli-Zhu mono-resistance), Towie (Trepri mono-resistance), Daboshu (Sindili mono-resistance), and Erika (Carrey Pearl Keytruda is a leader in the field, with more than 20 treatments approved, with global sales reaching $11.1 billion in 2019, up 58% from the previous year Mersadon has the largest clinical research program for immuno
oncology Currently, more than 1,200 clinical trials study Keytruda in a variety of cancer and treatment settings The project aims to understand the role of Keytruda in cancer treatment and to predict the factors that patients can benefit from Keytruda treatment, including exploring several different biomarker (biovalleybioon.com) original origin: Merck Reubmit Supplemental Biologic Licene Application (BLA) for KEYTRUDA ® (pembrozumab) Six-Week Schedule