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FDA Approves Cotellic in Combination With Zelboraf for Advanced Melanoma

The two Genentech drugs would treat BRAF V600E or V600K mutation-positive disease

The FDA has approved cobimetinib (Cotellic, Genetech) for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with vemurafenib (Zelboraf, Genetech).

“When used in combination, cobimetinib and vemurafenib help delay disease progression and help people live significantly longer than with vemurafenib alone,” said Sandra Horning, MD, Genentech’s chief medical officer. “With this approval, people with this type of deadly and aggressive skin cancer now have a new targeted option.”

The approval is based on results from the phase III coBRIM study, which showed cobimetinib plus vemurafenib improved progression-free survival (PFS) by about half in people who received the combination (hazard ratio [HR], 0.56; 95% confidence interval [CI], 0.45–0.70; P < 0.001), with a median PFS of 12.3 months for cobimetinib plus vemurafenib compared to 7.2 months with vemurafenib alone.

An interim analysis also showed the combination of cobimetinib and vemurafenib helped people live significantly longer (overall survival) than vemurafenib alone (HR, 0.63; 95% CI, 0.47–0.85; P = 0.0019). The objective response rate (tumor shrinkage) was higher with cobimetinib plus vemurafenib compared to vemurafenib alone (70% versus 50%; P < 0.001), as was the complete response rate (complete tumor shrinkage, 16% versus 10%).

Cobimetinib and vemurafenib are not used to treat melanoma with a normal BRAF gene.

Possible serious side effects with cobimetinib include risk of skin cancers, increased risk of bleeding, heart problems that can lead to inadequate pumping of the blood by the heart, rash, eye problems, abnormal liver test or liver injury, increased levels of an enzyme in the blood, and photosensitivity. The most common side effects of cobimetinib include diarrhea, sunburn or sun sensitivity, nausea, fever, and vomiting. Cobimetinib can also cause changes in blood test results.

The final overall survival analysis from the coBRIM study will be presented at the Society for Melanoma Research 2015 International Congress held in San Francisco, California, from November 18 to 21.

Cobimetinib will be available in the United States within two weeks. For those who qualify, Genentech plans to offer patient assistance programs for people taking cobimetinib in combination with vemurafenib through Genentech Access Solutions.

Source: Genetech, November 10, 2015.

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