FDA approves Mercay Heavy Anti-PD-1 Therapy Keytruda For Advanced/Metastatic Non-Small Cell Lung Cancer

today,The FDA's(http:// announcedapproval of the heavy-duty anti-PD-1 therapy, developed by the http://Company
,, as a single-drug therapy for PD-L1-positive late-stage/metastatic non-small cell lung cancer (NSCLC) patientsIn the treatment of lung cancer, Keytruda was initially approved in 2015 as a 2-line therapy for patients with advanced NSCLC who express PD-L1In October 2016, for the first time as a first-line therapy, a single drug was approved to treat metastatic NSCLC patients with PD-L1 high expression (TSP -50%)However, in lung cancer patients, the number of patients with high PD-L1 expression was only 30%this approval will reduce pD-L1 expression standards for patients who are suitable for Keytruda treatment to TPS to 1%, which may more than double the number of PD-L1-positive NSCLC patients suitable for Keytruda single-drug treatment, according to previous studies of pD-L1 expression level distribution in lung cancer patientsIn the keynote-042 study
PD-L1-positive metastatic NSCLC patients who were treated with Keytruda or chemotherapy did not carry eGFR or ALK gene mutationsThe results of the experimental(http://showed that the total survival of Keytruda single-drug therapy was better than that of the chemotherapy group, regardless of the psyche of PD-L1 expression of TPS, s.20%, or 1%In patients with TPS of 50%, the median survival of the Keytruda group and the chemotherapy group was 20.0 months and 12.2 months, respectively, and the risk of death in the Keytruda group was significantly reduced by 31%In patients with TPS of 20% and TPS to 1%, the risk of death was significantly reduced by 23% (median survival of 17.7 months vs 13.0 months) and 19% (16.7 months vs 12.1 months), respectivelyThe improve dysserving of Keytruda in the overall survival rate was comparable to chemotherapy, and even showed some advantages, but not statistically significant, according to theof the exploratoryanalysis(http://from a side-effect point of view, Keytruda single-drug therapy has fewer side effects than chemotherapy, making it possible to become a better first-line therapy