DOW JONES NEWSWIRES
Drug maker Bristol-Myers Squibb Co. (BMY) said the U.S. Food and
Drug Administration needs additional time to finish a review of the
license application for the company's melanoma treatment, pushing
back its decision date by three months.
The FDA said it now expects to make a decision on the license by
March 26 of next year, rather than Dec. 25 of this year. Bristol
has complied with a request for further analysis of data.
Ipilimumab is an experimental treatment for advanced melanoma, a
type of skin cancer.
In August, the FDA had agreed to give ipilimumab a priority
review, focusing on the use of the drug on patients who have
previously received treatment for melanoma.
Ipilimumab is also under review by other health agencies.
Last month, Bristol-Myers said its third-quarter profit declined
slightly from a year earlier on flat sales. The drug maker's
fortunes have brightened since a series of challenges in the
mid-2000s, including legal problems and temporary generic
competition for its top product, the anticlotting drug Plavix.
Shares closed at $26.90 and were inactive in recent late
-By Nathan Becker, Dow Jones Newswires; 212-416-2855;