Pierre Fabre Laboratories receives CHMP positive opinion for BRAFTOVI in combination with MEKTOVI for the treatment of adult patients with advanced non-small cell lung cancer NSCLC) with a BRAFV600E mutation
Natalia Elliot | July 29, 2024 | News story | Clinical Trial Services | BRAF mutation, CHMP, EMA, Oncology, Pierre Fabre Laboratories, colorectal cancer, european studies, non-small cell lung cancer
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 2 PHAROS trial was used to support the CHMP opinion. The study included 98 patients from 56 study centres across 5 countries.
BRAFTOVI in combination with cetuximab is currently approved in Europe for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAFV600E mutation who have received prior systemic therapy.
Ducournu continued: “We look forward to the European Commission’s decision to make BRAFTOVI + MEKTOVI available to non-small cell lung cancer patients in Europe.”
BRAFTOVI with MEKTOVI is currently approved in Europe for the treatment of adult patients with unresectable or metastatic melanoma with a BRAFV600E mutation.
Natalia Elliot
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