FDA accepts BLA filing of Opdivo to treat small cell lung cancer .- BMS.

Bristol-Myers Squibb Company announced that the FDA has accepted for priority review its supplemental Biologics License Application for Opdivo (nivolumab) to treat patients with small cell lung cancer (SCLC) whose disease has progressed after two or more prior lines of therapy. The FDA action date is 16 August 2018.

The submission was based on safety and efficacy data from the SCLC cohort of the Phase 1/II CheckMate -032 trial evaluating Opdivo monotherapy following platinum-based chemotherapy. About CheckMate-032 CheckMate -032 is a Phase 1/II open-label trial evaluating the safety and efficacy of Opdivo monotherapy or Opdivo plus Yervoy (ipilimumab) in advanced or metastatic solid tumors, including small cell lung cancer. Patients were treated until disease progression or unacceptable toxicity. The trial included both PD-L1 expressors and non-expressors. The primary objective was objective response rate as assessed by a blinded independent central review. Secondary objectives included safety, overall survival, progression-free survival and duration of response.