WASHINGTON (Reuters) ? U.S. drug regulators on Wednesday approved a new drug from Roche Holding for treating late-stage skin cancer.
The Food and Drug Administration approved the drug, under the brand name Zelboraf, along with a companion diagnostic that identifies which patients have a specific genetic mutation that means they will benefit from the treatment.
About half of all melanomas, the deadliest form of skin cancer, have the genetic aberration that the drug targets.
Roche filed for U.S. approval of the drug in April and the FDA had to make a decision by October 28.
Analysts have forecast annual Zelboraf sales for Roche of $732 million by 2015.
In March, the FDA approved the first treatment to help patients with advanced melanoma live longer. The drug Yervoy, or ipilimumab, is sold by Bristol-Myers Squibb.
(Reporting by Anna Yukhananov; editing by Dave Zimmerman)
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