The FDA has approved the skin cancer drug Cotellic for certain forms of melanoma in combination with another Roche cancer drug, Zelboraf.
Although Cotellic (cobimetinib) and Zelboraf (vemurafenib) are conventionally not used to treat melanoma with a normal BRAF gene, the approval for the combination dose has been given the green light.
The combination is now available for people with BRAF V600E or V600K mutation positive melanoma, that has either spread (is metastatic) or is unable to be removed by surgery (unresectable).
Sandra Horning, chief medical officer and head of global product development at Roche says: “When used in combination, Cotellic and Zelboraf help delay disease progression and help people live significantly longer than with Zelboraf alone. With this approval, people with this type of deadly and aggressive skin cancer now have a new targeted option.”
The FDA’s approval is based on results from the Phase III coBRIM study, which showed Cotellic plus Zelboraf reduced the risk of disease worsening or death by about half in people who received the combination, with a median PFS of 12.3 months for Cotellic plus Zelboraf compared to 7.2 months with Zelboraf alone.
An interim analysis also showed the combination of Cotellic and Zelboraf helped people live significantly longer than Zelboraf alone. The objective response rate (tumour shrinkage) was higher with Cotellic plus Zelboraf compared to Zelboraf alone, as was the complete response rate.
There are possible serious side effects with Cotellic, including an increased risk of skin cancers. Other side effects include an increased risk of bleeding, heart problems, rashes, eye problems, abnormal liver tests or liver injury, increased levels of an enzyme in the blood, and photosensitivity. However the most common side effects of Cotellic include diarrhea, sunburn or sun sensitivity, nausea, fever and vomiting.