FDA accepts filing of Tyvyt + Alimta for non-small cell lung cancer.- Innovent Biologics and Eli Lilly

Innovent Biologics and Eli Lilly and Company announced that the FDA accepted for review a Biologics License Application (BLA) for Tyvyt (sintilimab injection) in combination with Alimta (pemetrexed) and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small cell lung cancer (NSCLC). This is the first U.S. regulatory submission of sintilimab, a PD-1 inhibitor being developed and commercialized under a global collaboration agreement between Innovent and Lilly. This regulatory application was submitted to the FDA in March 2021, primarily based on the results of the Phase III ORIENT-11 trial. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA to make a decision on the sintilimab application is in March 2022. The FDA stated that it did not identify any potential review issues in its acceptance letter. It is currently planning to hold an Advisory Committee meeting to discuss this application.ORIENT-11 is a randomized, double-blind, Phase III clinical trial assessing the efficacy and safety of sintilimab in combination with pemetrexed and platinum chemotherapy compared to placebo in combination with pemetrexed and platinum chemotherapy as a first-line treatment for patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC), with no sensitizing EGFR mutations or ALK rearrangements. The primary endpoint is progression-free survival (PFS) as assessed by Independent Radiographic Review Committee (IRRC) based on RECIST v1.1., and secondary endpoints include overall survival (OS) and safety profile.