CHMP recommends Braftovi (encorafenib) + Mektovi (binimetinib)to treat adult patients with advanced non-small cell-lung cancer (NSCLC) with BRAFV600E mutation
Pierre Fabre Laboratories has announced a positive opinion from the European Medical Association’s (EMA) Committee for Medicinal Products Human use (CHMP) for their combination drugs to treat adult patients with advanced non-small cell-lung cancer (NSCLC) with BRAFV600E mutation
CHMP has issued a positive opinion recommending the approval of Braftovi(encorafenib) in combination with Mektovi (binimetinib), which has been submitted to the European Commission (EC). A decision on EU marketing authorisation (MA) will follow later this year.
Eric Ducournau, chief executive officer, Pierre Fabre Laboratories said: “The positive CHMP opinion marks a pivotal step in our commitment to delivering an additional effective targeted treatment option for patients with advanced NSCLC with a BRAFV600E mutation, who at present have limited treatment options.”
Data from the global, open-label, multicentre, non-randomised phase II PHAROS trial was used to support the CHMP opinion. The study included 98 patients from 56 study centres across 5 countries.
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