New treatment approved for advanced melanoma

10 Nov 2015

The U.S. Food and Drug Administration approved Roche's Cotellic to be used in combination with the company's Zelboraf drug to treat BRAF V600 mutation-positive advanced melanoma.

The FDA decision had been expected this month and was issued on Tuesday, 10th of November. It applies to advanced melanoma that spreads to other parts of the body or that cannot be removed by surgery, the U.S. regulatory agency said in a statement.

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European approval will be issued soon

It follows approval in August of the combination of Cotellic and Zelboraf in treating advanced melanoma in Switzerland.  An EU advisory panel has also recommended Cotellic in combination with Zelboraf. A decision by the European Commission is expected by the end of the year.

Last month, Basel-based Roche said final survival data from a Phase 3 clinical trial showed Cotellic and Zelboraf helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live significantly longer than Zelboraf alone.

Source: Reuters
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