Posted by Michael Wonder on 17 Aug 2018
U.S. FDA approves Opdivo (nivolumab) as the first new medication in nearly 20 years for certain patients with previously treated small cell lung cancer
17 August 2018 - Opdivo is now the first immuno-oncology treatment approved for small cell lung cancer patients who received platinum-based chemotherapy and at least one other line of therapy.
Bristol-Myers Squibb today announced that Opdivo (nivolumab) received approval from the U.S. FDA as the first and only immuno-oncology treatment option for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indication has been granted under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
This approval for Opdivo in patients with SCLC whose cancer has progressed after two or more prior lines of therapy was granted priority review from the FDA.
The approval was based on data from the SCLC cohort of the ongoing Phase 1/2 CheckMate-032 study evaluating Opdivo in patients who experienced disease progression after platinum-based chemotherapy.
