FDA Awards BMS’ Opdivo Expanded Indications

Last week was a busy one for Bristol-Myers Squibb’s Opdivo, which received multiple indications from the FDA to treat different forms of cancer.

On Monday, the agency approved Opdivo (nivolumab) to treat patients with advanced renal cell carcinoma who have received prior therapy. A randomized 821-patient study of the drug found that those treated with Opdivo lived an average of 25 months after starting treatment, compared with 19.6 months in those treated with Novartis’ Afinitor (everolimus).

The company then announced on Tuesday that the agency approved the drug as a single agent for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma after it reached its primary endpoint in a Phase 3 trial. The study evaluated overall survival in treatment-naïve patients taking Opdivo or dacarbazine.

Opdivo currently has regulatory approval in 40 countries, including the U.S., EU and Japan.