FDA Extends Review of Bristol-Myers Melanoma Drug

From Associated Press (November 2, 2010)

PRINCETON, N.J. -- Drugmaker Bristol-Myers Squibb Co. said Tuesday that federal health regulators have extended their review of the company's experimental skin cancer drug ipilimumab.

The company said the Food and Drug Administration pushed back its target date on the drug from Dec. 25 to March 26, 2011.

Bristol-Myers has asked the FDA to approve ipilimumab for patients with advanced melanoma, the deadliest form of skin cancer. Bristol-Myers said the FDA is taking additional time to review new data about the drug's use in pre-treated melanoma patients, which the company submitted at the agency's request.

Study results published earlier this year showed average patient survival time was 10 months with ipilimumab versus just over six months for patients using traditional therapies.

Shares of Bristol-Myers fell 17 cents to close at $26.90.
 

Posted: November 2010


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