FDA accepts applications for license seeking license for supplementary biologics from Peridome's Squibb Opdivo and low-dose Yervoy

recently, the(BMS) of Theof Periasi announced that the U.SFDA(which has accepted supplemental biologic license applications (s) for Opdivo (nivolumab) and low-dose Yervoy (ierumiumpilab), and that the first-line treatment of tumor mutation loads (TMB) is 10 mutations/megabits (mupl/Mb) patients with advanced non-small cell lung cancer (NSC)OpdivoOpdivo is the world's first approved PD-1 immunocheckpoint inhibitor, adrug(currently approved in more than 60 countries and regions, including the United States, the European Union and Japan)The Opdivo and Yervoy combination drug program became the first approved combination immunotherapy for metastatic melanoma, which has been approved by more than 50 countries, including the United States and the European Unionrelated studies
the application for this sBLA is based on the results of Part 1 of the CheckMate-227 study, a global Phase 3 clinical study that evaluates the efficacy of I-O/I-O in first-line treatment in Patients with NSCLC with TMB of 10 mut/Mb, spanning scaly and non-scale tumor histology and PD-L1 expression spectrum compared to chemotherapy protocolThe data were presented this year at the annual meeting of the American Association for Cancer Research (AACR) and published in the New England Journal of MedicineCheckMate-227 is an ongoing multi-part, open label, phase 3 clinicaltrialto assess the efficacy of first-line treatment of advanced NSCLC patients in scaly and non-scale tumor histology compared to platinum double chemotherapyPart 1 has two common primary endpoints: total survival (OS) in patients with tumor expression PD-L1, and progressionless survival (PFS) in patients with tumors that span PD-L1 spectrum of TMB to 10mut/Mb The TMB status is evaluated by the verified Foundatio nOne CDx Opdivo and Yervoy doses in this study were: Opdivo 3 mg/kg every two weeks and low dose of Yervoy 1 mg/kg every six weeks results showed that Opdivo plus low-dose Yervoy combination therapy showed a better PFS endpoint than chemotherapy, reducing the risk of disease progression or death by 42% (HR 0.58; 97.5% CI: 0.41-0.81; p-0.0002) The PFS benefits can be observed in scaly and non-scaly tumor histology regardless of pD-L1 expression level In addition, analytical based on early descriptive (in patients with high TMB, the combination therapy also showed better OS results than chemotherapy (HR 0.79; 95% CI: 0.56-1.10)