The US Food and Drug Administration has green lighted Roche’s Cotellic for use in combination with Zelboraf to treat some patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma.

Approval was issued on the back of Phase III data showing that the combination cut the risk of disease worsening or death by about half, with a median PFS of 12.3 months for Cotellic (cobimetinib)/Zelboraf (vemurafenib) versus 7.2 months with Zelboraf alone, while an interim analysis has also shown that the combo helped patients live significantly longer, Roche said.

Tumour shrinkage was also higher in the group receiving the combo compared to those taking Zelboraf alone (70% versus 50%), and complete tumour shrinkage was observed in 16% versus 11%, respectively.

On the downside, possible serious side effects with Cotellic 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. 

Nevertheless, the approval, says Richard Pazdur, director of the Office of Haematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, “provides a new targeted treatment that, when added to vemurafenib, demonstrates greater benefit than vemurafenib alone in patients with BRAF mutation-positive melanoma”.

“As we continue to advance our knowledge of tumour 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,” he noted.

The drug has also won the support of Europe’s Committee for Medicinal Products for Human Use, which recommended its approval for advanced melanoma late September. The drug picked up its first global approval in Switzerland back in August.