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FDA Approves New Drug Combination Treatment for Melanoma Patients

Update Date: Nov 11, 2015 12:32 PM EST

Patients diagnosed with melanoma, the deadliest form of skin cancer, will have another treatment option available to them.

The U.S. Food and Drug Administration (FDA) approved the drug combination of Cotellic (cobimetrinib) with Zelboraf (vemurafenib), drugs manufactured by the Swiss company, Roche, for patients with BRAF V600K or BRAF V600E mutation-positive advanced melanoma. In patients with this specific mutation, the cancer has already spread and cannot be removed via surgery.

The FDA's approval was expected to come this month especially since treatment plans have been moving toward drug combinations. The combination of Cotellic and Zelboraf was just approved in Switzerland this past August. The combination therapy should also be approved by the European Commission before the end of the year.

"As we continue to advance our knowledge of tumor biology, we have learned that cancer cells have a remarkable ability to adapt and become resistant to targeted therapies. Combining two or more treatments addressing different cancer-causing targets may help to address this challenge," said Richard Pazdur, M.D. reported in the news release. "Today's approval provides a new targeted treatment that, when added to vemurafenib, demonstrates greater benefit than vemurafenib alone in patients with BRAF mutation-positive melanoma."

The approval came after the results from a Phase III clinical trial that involved 495 patients concluded that people on the drug combination treatment plan lived longer than people who only took Zelboarf. After 17 months, 65 percent of the drug-combination group was still alive. For the targeted treatment group, the rate was only at 50 percent.

Patients on the combination therapy also lived for a longer period of time than patients taking Zelboraf before their cancer got worse. Patients taking both drugs experienced worsened conditions from their cancer after 12.3 months. For patients who were only taking Zelboarf, their conditions worsened after 7.2 months. Cotellic - Zelboraf was also more effective at reducing tumor size than Zelboraf alone.

Common side effects of taking both drugs included diarrhea, nausea, fever, vomiting and sensitivity to ultraviolet light.

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