FDA Appproves Expanded Use for BMS’ Opdivo/Yervoy

FDA has approved a Bristol-Myers Squibb NDA for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for treating patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. The indication was approved under the agency’s accelerated approval program based on progression-free survival (PFS). FDA also expanded the use of Opdivo as a single-agent to include previously untreated BRAF mutation-positive advanced melanoma patients. The drug was approved 11/2015 for use in previously untreated patients with BRAF V600 wild-type unresectable or metastatic melanoma.

The expanded approval was based on data from a study called CheckMate -067. “Median PFS was 11.5 months (95% ci:8.9-16.7) for the Opdivo plus Yervoy regimen and 6.9 months (95% ci:4.3-9.5) for Opdivo monotherapy, vs. 2.9 months (95% ci:2.8-3.4) for Yervoy monotherapy,” the company says.