CHMP recommends EU approval for Roche’s Cotellic and Zelboraf combo

25 September 2015

Swiss pharma giant Roche (ROG: SIX) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Cotellic (cobimetinib), when used in combination with Zelboraf (vemurafenib), for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma.

Approximately 50% of melanoma skin cancers are BRAF-positive, and more than 55,000 people worldwide die every year from melanoma.

“Powerful therapeutic option”

"Today’s CHMP positive opinion is a substantial step forward for people with BRAF-positive skin cancer in Europe and around the world," said Sandra Horning, chief medical officer and global head of product development, adding: “The Cotellic and Zelboraf combination will provide physicians with a powerful therapeutic option that can help patients live significantly longer without their disease progressing compared to Zelboraf alone."

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