ARTICLE | Regulation

Defying convention

Why FDA accepts serious risks to approve BMS's Yervoy for melanoma

April 11, 2011 7:00 AM UTC

Yervoy ipilimumab to treat first-line metastatic melanoma provides some visibility into FDA's calculation of risk-benefit, as the agency did not adhere to convention in approving an effective new drug with serious or fatal adverse events.

Yervoy, from Bristol-Myers Squibb Co., is the first drug to show a survival benefit in the disease, prolonging overall survival by 3.6 months...