Pierre Fabre Laboratories announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAFV600E mutation. This positive opinion will now be submitted to the European Commission (EC) for a decision on EU marketing authorization, expected later this year.

Eric Ducournau, Chief Executive Officer of Pierre Fabre Laboratories, commented, "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 currently have limited treatment options. We look forward to the European Commission's decision to make BRAFTOVI® + MEKTOVI® available to non-small cell lung cancer patients in Europe."

The CHMP positive opinion is supported by data from the global, open-label, multicentre, non-randomised Phase II PHAROS trial, which included 98 patients from 56 study centres across five countries.

At the primary analysis (cut-off date: September 22, 2022), the primary endpoint of the trial (objective response rate [ORR] determined by independent radiology review [IRR]) was met. The PHAROS trial showed that in patients with advanced NSCLC with a BRAFV600E mutation, BRAFTOVI® and MEKTOVI® provided a meaningful clinical benefit with an ORR of 75% (95% CI: 62, 85) in treatment-naïve patients (n=59), with 59% maintaining their response for at least 12 months. For patients who had received prior therapy (n=39), the ORR was 46% (95% CI: 30, 63), with 33% maintaining their response for at least 12 months.

The safety profile of BRAFTOVI® and MEKTOVI® in this trial was consistent with that observed in the approved metastatic melanoma indication.

Pierre Fabre Laboratories anticipates the European Commission's decision later this year and is preparing to make this treatment option available to patients across Europe.