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Biotech Stocks Facing FDA Decision in April

Bristol Myers
Bristol Myers

Bristol-Myers Squibb Co.’s (BMY) supplemental Biologics License Application for Opdivo plus Yervoy to treat intermediate-and poor-risk patients with advanced renal cell carcinoma is under priority review – with a decision expected on April 16, 2018.

This supplemental Biologics License Application was based on the results of CheckMate -214, a phase III study that evaluated the combination of Opdivo plus Yervoy versus Pfizer’s Sutent in patients with previously untreated advanced or metastatic renal cell carcinoma.

The study met the co-primary endpoints of improved overall survival and objective response rate compared to Sutent in intermediate- and poor-risk patients. While the combination demonstrated an improvement in progression-free survival relative to Sutent, another co-primary endpoint, it did not reach statistical significance.

Opdivo and Yervoy are blockbuster drugs of Bristol-Myers. In 2017, the global sales of Opdivo were $4.95 billion, up 31% over 2016, and that of Yervoy totaled $1.24 billion, up 18% over 2016.

BMY closed Tuesday’s (Mar.27) trading at $62.41, down 1.56%.