October 6, 2015 / 5:25 AM / 4 years ago

Roche says data shows Cotellic combination therapy effective

The logo of Swiss pharmaceutical company Roche is seen at a plant in the central Swiss village of Rotkreuz November 6, 2013. REUTERS/Arnd Wiegmann

ZURICH (Reuters) - Swiss drugmaker Roche said final survival data from a Phase III clinical trial showed the Cotellic drug used in combination with Zelboraf helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live significantly longer compared to Zelboraf alone.

Ongoing monitoring did not identify any new safety signals. Long-term safety data was expected later this year, it added in a statement on Tuesday. Cotellic was discovered by Exelixis Inc and is being developed by Roche and Exelixis.

Last month, an EU advisory panel recommended Cotellic in combination with Zelboraf. A decision by the European Commission is expected by the end of 2015. A decision from the U.S. Food and Drug Administration (FDA) on Roche’s new drug application is expected by Nov. 11, it said.

Reporting by Michael Shields

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