According to a report in the San Francisco Business Times by Ron Leuty, the drug was approved in August by the U.S. Food and Drug Administration, with a European panel recommending approval in December.
Plexxikon is owned by Daiichi Sankyo.
The approvals are expected to benefit people with BRAF mutation-positive metastatic melanoma, researchers reported in analyzing clinical trial results.
Dr. Hal Barron, Roche's chief medical officer, said Zelboraf significantly improves patient survival, according to the article.
Zelboraf also has been approved in Canada, Switzerland, Brazil, Israel and New Zealand. It is being reviewed in Australia, India and other countries, Roche said.
Zelboraf is marketed in the United States by South San Francisco-based Genentech Inc., a Roche subsidiary.
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