FDA accepts Bristol-Myers Squibb's filing for Opdivo/Yervoy regimen in advanced melanoma

The US Food and Drug Administration has accepted a filing from Bristol-Myers Squibb (NYSE: BMY) seeking approval of its PD-1 inhibitor Opdivo (nivolumab) in combination with CTLA-4 inhibitor Yervoy (ipilimumab) for previously-untreated advanced melanoma.

Bristol-Myers Squibb said that the FDA assigned priority review to the application and is expected to make a decision by September 30. The submission includes data from the Phase II study CheckMate -069, evaluating Opdivo and Yervoy in patients with previously-untreated advanced melanoma. Results showed that patients with BRAF wild-type mutation status treated with the regimen experienced improved objective response rate as compared to patients administered Yervoy alone. Data showed that the combination of Opdivo and Yervoy achieved an objective response rate of 61%, including a 22% complete response rate.

Opdivo became the first PD-1 inhibitor available anywhere following its Japanese launch last September. It gained accelerated approval by the FDA to treat melanoma, while the indication was expanded in March to include advanced squamous non-small-cell lung cancer in some patients.