FDA grants accelerated approval for Opdivo for patients with metastatic small cell lung cancer . BMS.

Bristol-Myers Squibb Company announced that Opdivo (nivolumab) received approval from the 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 (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial.

The approval was based on data from the SCLC cohort of the ongoing Phase 1/II CheckMate -032 study evaluating Opdivo in patients who experienced disease progression after platinum-based chemotherapy. Of 109 patients receiving Opdivo after platinum-based chemotherapy and at least one other prior line of therapy, 12% (n=13/109; 95% CI: 6.5-19.5) responded to treatment based on assessment by a Blinded Independent Central Review (BICR), regardless of PD-L1 expression. Twelve patients had a partial response (11%), and one patient had a complete response (0.9%).. Among these responders, the median DOR was 17.9 months (95% CI: 7.9-42.1; range: 3.0-42.1 months). Opdivo was discontinued in 10% of patients, and one dose was withheld in 25% of patients for an adverse reaction. Serious adverse reactions occurred in 45% of patients. The approved dosing for Opdivo in this indication is 240 milligrams administered every 2 weeks by intravenous infusion until disease progression or unacceptable toxicity.Small cell lung cancer is one of two main types of lung cancer and accounts for about 10% to 15% of all lung cancers.

Comment; Small cell lung cancer is an aggressive disease, and symptoms often are not detected until the cancer is at an advanced stage. In the United States, about 27,000 cases of SCLC are expected to be diagnosed in 2018. From the time of diagnosis, five-year survival rates for extensive stage SCLC, or Stage IV, are about 2%.6.