EMA validates Pierre Fabre lung cancer combo MA

The European Medicines Agency (EMA) has validated the submission for Braftovi (encorafenib) with Mektovi (binimetinib), submitted by privately-held French drugmaker Pierre Fabre, for the treatment of adult patients with BRAFV600-mutant advanced non-small cell lung cancer (NSCLC), who are either treatment naïve or have received prior therapy.

The submission is based on the results from the registrational PHAROS study, which by independent review, showed an objective response rate (ORR) of 75% in treatment-naïve patients, with 59% maintaining a response for at least 12 months, and 46% in previously treated patients.

“Lung cancer is the number one cause of cancer death worldwide, and there are currently limited effective targeted treatment options for patients with BRAFV600-mutant advanced NSCLC. With our strategic focus on lung cancer and oncology precision medicine, this submission is the next step in delivering clinically-meaningful change to oncology patient populations with high unmet needs,” said Eric Ducournau, chief executive of Pierre Fabre Laboratories.