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Roche posts positive Cotellic data ahead of anticipated EU approval

Comes after FDA and Swiss approvals and CHMPrecommendation

Roche has presented positive data on its new melanoma drug Cotellic in combination with Zelboraf.

Data from the phase III coBRIM trial involving 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastic melanoma showed Cotellic plus Zelboraf reduced the risk of death by 30% compared to Zelboraf alone.

Additionally combining the drugs helped patients live an additional five months longer with a median overall survival rate of 22.3 months.

Sandra Horning, chief medical officer and head of global product development at Roche, said: “With about half of the people taking Cotellic and Zelboraf alive after two years, these data underscore the progress being made in cancer research towards better patient outcomes.

“Five years ago, the survival rate for BRAF mutation-positive advanced melanoma was measured in months, and now we are measuring it in years.”

The results come just after Roche received FDA approval for Cotellic (cobimentib) and Zelboraf (vemurafenib) earlier this month.

Roche has also recently secured approval from Swiss regulators and earned itself a positive opinion from the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP), putting it well on its way to full European approval.

Cotellic is also currently being studied in combination with numerous investigational medicines; including an immunotherapy in severe tumour types such as non-small cell lung cancer and colorectal cancer.

Melanoma is a less common, but more aggressive and deadlier, form of skin cancer. More than 232,000 people worldwide are currently diagnosed with melanoma each year, however most people still continue to have a poor prognosis. 

Article by
Nikhil Patel

23rd November 2015

From: Research



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