FDA approves Cotellic plus Zelboraf in advanced melanoma

The US Food and Drug Administration (FDA) has approved Roche’s Cotellic (cobimetinib) in combination with Zelboraf (vemurafenib) for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma.

Cotellic is Roche’s seventh new medicine approved by the FDA in the past five years.

“When used in combination, Cotellic and Zelboraf help delay disease progression and help people live significantly longer than with Zelboraf alone,” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. “With this approval, people with this type of deadly and aggressive skin cancer now have a new targeted option.”

Cotellic plus Zelboraf reduced the risk of disease worsening

The FDA 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 progression-free survival (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 (tumor shrinkage) was higher with Cotellic plus Zelboraf compared to Zelboraf alone (70 vs. 50 percent), as was the complete response rate (complete tumor shrinkage, 16 vs. 11 percent).

In September, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) issued a positive opinion for Roche’s marketing authorization application for Cotellic in the European Union. A decision from the European Commission is expected before the end of 2015. Cotellic was approved in Switzerland by Swissmedic in August 2015.