FDA accepts Mercadon KEYTRUDA single drug or combined platinum and 5-fluoromyacil for HNSCC supplementary biological products listing application

head and neck cancer refers to a variety of different tumors around the throat, nose, sinuses and mouthMost head and neck cancers are squamous cell carcinomas that begin with flat squamous cells that form the thin surface of the head and neck structurerecently, the http://of thePharmaceuticals of The United States said that theFDA http://
has accepted thecompany's(http://anti-PD-1 therapy KEYTRUDA single drug or co-platinum and 5-fluoromyquine for recurrent or metastatic cervical squamous cell carcinoma (HNSCC) first-line treatment of complementary biological products (BLAs)The FDA has given this sBLA priority review and set a PDUFA date of June 10, 2019this sBLA is based in part on key clinical phase 3trial(http://KEYNOTE-048in this trial, KEYTRUDA showed a significant improvement in total patient survival (OS) duration, whether it was a single drug for PD-L1 comprehensive proportional score (CPS) and CPS s1 patients, or combined chemotherapy for the entire patient population The figures were published at the european medical oncology Conference (http:// in 2018 　　KEYNOTE-048 is a randomized, open-labeled Phase 3 trial (ClinicalTrials.gov, NCT02358031) that evaluated 882 patients with recurrent or metastatic HSNCC in the first-line treatment of TRUKEYDA single-drug or combined EXTREME chemotherapy protocol major endpoints include OS and Progressionless Survival (PFS), and secondary endpoints include PFS (6 and 12 months), objective mitigation rates, the European Organization for Cancer Research and Treatment (EORTC) global health (http:// conditions/quality of life scales Mitigation Duration (DOR) is evaluated as part of the pre-specified exploratory Analysis (http:// the study was analyzed in the whole population with PD-L1 CPS s20 and CPS s1 and No In data analysis, the median follow-up time for KEYTRUDA single-drug treatment was 11.7 months, the median follow-up time for the joint programme was 13.0 months, and the median follow-up time for THE EXTREME program was 10.7 months 　　KEYNOTE-048 is also a validation trial of KEYNOTE-012, a clinical 1b phase study that supports accelerated approval for patients with relapsed or metastatic HNSCC in or after platinum chemotherapy in previous KEYTRUDA single-drug treatment