The US Food and Drug Administration (FDA) has granted approval for Roche ‘s Cotellic (cobimetinib) in combination with Zelboraf (vemurafenib) to treat people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma.
The company noted that both Cotellic and Zelboraf are not used to treat melanoma with a normal BRAF gene.
Cotellic is the company’s seventh new medicine approved by the FDA in the past five years.
The 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.
Roche Global Product Development head and chief medical officer Dr Sandra Horning said: "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."
An interim analysis also showed the combination helped people live significantly longer than Zelboraf alone.
The data also showed that the objective response rate (tumour shrinkage) was higher with Cotellic plus Zelboraf compared to Zelboraf alone, as was the complete response rate.
The international, randomised, double-blind, placebo-controlled Phase III CoBRIM trial evaluates the safety and efficacy of 60mg once daily of Cotellic plus 960mg twice daily of Zelboraf compared to 960mg twice daily of Zelboraf plus placebo.
A total of 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma and previously untreated for advanced disease were included in the trial, and they were randomised to receive Zelboraf every day on a 28-day cycle plus either Cotellic or placebo on days 1-21.
The trial’s primary endpoint was investigator-assessed PFS and the secondary endpoints include PFS by independent review committee, objective response rate, overall survival, duration of response and other safety, pharmacokinetic and quality of life measures.
In September, the European Medicines Agency ‘s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Roche’s marketing authorisation application for Cotellic in the European Union (EU).