Bristol-Myers Squibb ($BMS) has revealed that the FDA will require more time to review its BLA for ipilimumab, an investigational drug for the treatment of advanced melanoma. The agency has moved its decision date from December 25 to March 26, 2011. In response to an FDA request, BMS submitted further analysis of melanoma data; the agency considers this to be a major amendment to the drug's BLA and will need more time to review the company's submission.
BMS got ipilimumab back in 2009 with its buyout of Medarex, part of a strategy to remake its pipeline and gain late-stage prospects with blockbuster revenue potential. Although the drug has been linked to severe side effects, analysts have forecast peak sales of $1 billion to $1.5 billion based on its approval for patients with few treatment options.
- here's the BMS release
- take a look at the Reuters write-up