Eu approves Cotellic (cobimetinib) plus Zelboraf (vemurafenib) for unresectable or metastatic melanoma with a BRAF V600 mutation- Roche

Roche announced that the European Commission has approved Cotellic (cobimetinib) for use in combination with Zelboraf (vemurafenib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. The EU approval is based on data that showed Cotellic plus Zelboraf helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live for more than a year without their disease worsening.

EU approval is based primarily on results of the Phase III coBRIM study, which showed that people with previously untreated BRAF V600 mutation-positive advanced melanoma who were being treated with the MEK inhibitor Cotellic in combination with Zelboraf lived a median of one year (12.3 months) without their disease worsening or death (progression-free survival; PFS) compared to 7.2 months with Zelboraf alone. The objective response rate (ORR) with the combination was 70 percent (16 percent complete response [CR], 54 percent partial response [PR]) compared to 50 percent (11 percent CR, 40 percent PR) in the Zelboraf arm. The safety profile of Cotellic plus Zelboraf was consistent with safety data previously reported. The most common adverse events in the combination arm were diarrhea, rash, nausea, fever, sun sensitivity, liver lab abnormalities, elevated creatine phosphokinase (CPK, an enzyme released by muscles) and vomiting. The FDA approved this combination for unresectable or metastatic melanoma with a BRAF V600 mutation earlier in November.