Roche announced Monday that the European Commission approved Zelboraf (vemurafenib) as a monotherapy for the treatment of adults with BRAF V600 mutation-positive unresectable or metastatic melanoma. The company noted that the decision makes the oral BRAF inhibitor the “first and only personalised skin cancer medicine” currently available in Europe.
The authorisation, which follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use in December, was based on data from the late-stage BRIM3 trial. Results of the study showed that the risk of death was reduced by 63 percent for patients who received Zelboraf compared to those who received standard first-line treatment. In addition, Roche’s therapy significantly improved survival over standard first-line treatment by providing a median overall survival of 13.2 months versus 9.6 months for chemotherapy.
“Today’s approval…exemplifies the benefits that Roche’s personalised approach to medicine can provide,” remarked chief medical officer Hal Barron. Zelboraf was co-developed with the cobas 4800 BRAF V600 Mutation Test, which is commercially available in the EU and is used to identify patients eligible for treatment with the drug. According to the company, mutated forms of the BRAF protein are found in about half of all cases of melanoma.
In August last year, Zelboraf garnered FDA approval simultaneously with the cobas 4800 BRAF V600 Mutation Test. In the U.S., the agent is jointly marketed by Roche’s Genentech unit and Daiichi Sankyo. The Swiss drugmaker noted that Zelboraf also recently received clearance in Switzerland, Brazil, Israel, Canada and New Zealand and is under review in Australia, India and other countries.
Commenting on the new approval, Vontobel analyst Andrew Weiss said “we already included a positive European regulatory decision scenario in our model and thus make no changes to our estimates, and we carry peak sales for Zelboraf of 1.3 billion Swiss francs ($1.4 billion).”