United States-based Bristol-Myers Squibb has received US Food and Drug Administration (FDA) approval for its Opdivo 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, it was reported yesterday.

The company has received approval for this indication under accelerated approval based on overall response rate and duration of response.

Continued approval for this indication is likely to be contingent upon verification and description of clinical benefit in confirmatory trials.

This approval for the product is for patients with SCLC whose cancer has progressed after two or more prior lines of therapy and was granted priority review from the US FDA. It was based on data from the small cell lung cancer cohort of the ongoing Phase 1/2 CheckMate -032 study assessing Opdivo in patients who experienced disease progression after platinum-based chemotherapy.