FDA expands approval of Opdivo (nivolumab) to treat advanced melanoma- BMS

The FDA has expanded the use of Opdivo (nivolumab) from BMS, as a single-agent to include previously untreated BRAF mutation-positive advanced melanoma patients. The use of Opdivo as a single-agent in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Opdivo was approved by the FDA in November 2015, for use in previously untreated patients with BRAF V600 wild-type unresectable or metastatic melanoma.

Comment: This expanded indication puts Opdivo on a similar indication to its competitor Keytruda from Merck Inc. to treat previously untreated patients with advanced melanoma.