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Melanoma patient advocates praised the FDA for clearing the drug well ahead of an Oct. 28 target date to complete its review.
"The FDA's quick action on this drug approval is important because it gives melanoma patients a new way to fight this deadly disease," Timothy Turnham, director of the Melanoma Research Foundation, said in a statement.
In June, Roche's Genentech agreed to study Zelboraf in combination with Bristol-Myers' Yervoy, the only other melanoma drug shown to extend life.
Zelboraf was co-developed by Roche's Genentech unit, based in South San Francisco, Calif., and Daiichi Sankyo, a Japanese drugmaker. The companies will co-promote the drug in the U.S.
Roche said Wednesday the drug would be available within two weeks.
The drug is under review in the European Union and more than a half-dozen other countries around the world.
Copyright 2011 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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