Pierre Fabre has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the use of Braftovi (encorafenib) and Mektovi (binimetinib) combination to treat melanoma.
The indication covers treatment of adults suffering from unresectable or metastatic melanoma with a BRAFV600 mutation.
Braftovi is an oral small-molecule inhibitor of BRAF kinase, while Mektovi blocks MEK that targets enzymes in the MAPK signalling pathway.
Pierre Fabre Pharmaceuticals division president & CEO Frédéric Duchesne said: “We are delighted to be one step closer to bringing Braftovi and Mektovi to patients with advanced BRAF-mutant melanoma in Europe.
“If the European Commission approves Braftovi and Mektovi, this will be a new treatment option for these patients who currently have a challenging prognosis.”
The CHMP’s positive opinion comes after review of results from the Phase III Columbus clinical trial conducted to assess the safety and efficacy of the combination therapy in a total of 921 subjects at more than 200 sites across North and South America, Europe, Asia, Africa and Australia.
During the two-part, international, randomised, open-label trial, the Braftovi and Mektovi combination was compared with vemurafenib and encorafenib monotherapy.
Results showed improved median progression-free survival (PFS) of 14.9 months with the combination therapy, compared to 7.3 months using vemurafenib alone.
The median overall survival (OS) in patients treated with the combination was found to be 33.6 months, compared to 16.9 months in those administered with vemurafenib.
Pierre Fabre has exclusive rights to develop and commercialise Braftovi and Mektovi in all countries, except the US, Canada, Israel, Japan and South Korea.
The US and Canadian rights for the drugs are held by Array BioPharma. Medison has the exclusive rights in Israel, and Ono Pharmaceutical in Japan and South Korea.