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April 30, 2020 /
PRNewswire
BIOON/ -- Merck and Co has announced that the U.S Food and Drug Administration (
FDA ) has approved the anti-PD-1 therapy Keytruda (Creeda, GENERAL Motors) Name: pembrolizumab, Pabloli zumab) A new administration program - 400 mg (400mg Q6W) every 6 weeks for all approved adult indications, including monodotherapy and combination therapy The program is specific: every 6 weeks 400 mg intravenous infusion medicine, infusion time is not less than 30 minutes currently, Keytruda's medication regimen is 200mg (200mg Q3W, intravenous infusion situ for no less than 30 minutes) every 3 weeks The approved 400mg Q6W solution will provide patients with a more user-friendly treatment option with less frequency of administration, which will provide patients and oncologists
with greater treatment flexibility 400mg Q6W program was approved under the accelerated approval process based on pharmacokinetic data, exposure and efficacy data, exposure and safety The continued approval of this program will depend on the validation and description of clinical benefits in the of the of the validation of clinical trials in the EU, Keytruda 400mg Q6W administration was approved at the end of March 2019 for all approved single-drug treatment strains in Keytruda, covering five types of tumor types of 8 indications, including: non-small cell lung cancer (NSCLC), melanoma , bladder cancer, head and neck cancer, classic Hodgkin's lymphoma just recently, Mercado released the first clinical data for the 400mg Q6W program The interim data for the treatment of metastatic melanoma phase I KEYNOTE-555 study cohort B show that the efficacy and safety of the 400mg Q6W administration is comparable to that of the currently approved 200mg Q3W administration Interim data show that the total remission rate (ORR) for patients treated with Keytruda 400mg Q6W was 38.6% (n?17/44; 95% CI: 24.4-54.5) "The important social alienation measures taken against COVID-19 pose many challenges for cancer patients, including compliance with the planned treatment schedule," said Dr Roy Bayne, Chief Medical Officer, Senior Vice President and Head of Global Clinical Development, 's Mercadon Research Laboratory Today's approval of the Keytruda Q6W administration allows doctors to choose to reduce the frequency of patient treatment at the clinic "
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
1-
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 of $11.1 billion in 2019 In the first quarter of 2020, Moshadon reported global sales of $12.1 billion, up 11 percent from a year earlier, with Keytruda's sales at $3.3 billion, up 45 percent from the same period last 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: FDA Approve Merck'S KEYTRUDa ® (pembrolizumab) for Ue at an Additional Recommended Doe of 400 mg Every Six Week for All
roved Adult