• European approval is based on results from the Phase II PHAROS trial, which showed a meaningful clinical benefit to BRAFV600E mutated advanced NSCLC patients with an objective response rate (ORR) of 75% in treatment-naïve patients and 46% in previously treated patients. The safety profile is consistent with that observed in the approved metastatic melanoma indication.
• The approval follows a positive opinion issued on July 25 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)

Pierre Fabre Laboratories announced that the European Commission (EC) has approved BRAFTOVI^® (encorafenib) in combination with MEKTOVI^® (binimetinib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAF^V600E mutation. The approval is based on the results from the Phase II PHAROS trial, a global, open-label, multicentre, non-randomised trial to determine the efficacy and safety of BRAFTOVI^® + MEKTOVI^® in treatment-naïve and previously treated patients with BRAF^V600E mutant metastatic NSCLC.

"We are pleased to be able to extend the treatment of BRAFTOVI^® (encorafenib) in combination with MEKTOVI^® (binimetinib) to adult patients with advanced NSCLC with a BRAF^V600E mutation in Europe" said Eric Ducournau, Chief Executive Officer of Pierre Fabre Laboratories. "There are currently limited targeted treatment options for BRAF^V600E mutant NSCLC patients, so this approval is a significant milestone as BRAFTOVI^® + MEKTOVI^® will give patients the option of an additional effective targeted therapy."

The EC decision, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) issued on 25 July, is based on the results from the Phase II PHAROS trial. At 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. In the treatment-naïve population (n=59), the ORR was 75% (95% CI: 62, 85), including 15% complete responses (CRs) and 59% partial responses (PRs).^[1-3] Updated results with an additional 10-month follow-up showed that 64% of patients maintained a response for at least 12 months, with a median duration of response (mDOR) per IRR of 40 months (95% CI: 23.1, not estimable [NE]).