European Commission Approves BRAFTOVI and MEKTOVI for Lung Cancer

The European Commission has approved BRAFTOVI® and MEKTOVI® for treating advanced non-small cell lung cancer with the BRAFV600E mutation. Based on Phase II PHAROS trial results, the treatment shows significant efficacy in both naive and previously treated patients.

Pierre Fabre Laboratories has announced that the European Commission (EC) has approved the combination therapy of BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) for the treatment of advanced non-small cell lung cancer (NSCLC) with a BRAFV600E mutation. This approval, following a robust recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), represents a critical step forward in targeted therapies for patients with limited treatment options.

The EC decision, based on the Phase II PHAROS trial, highlights significant clinical benefits, including a 75% objective response rate (ORR) in treatment-naïve patients and a 46% ORR in previously treated patients. The safety profile was consistent with previous findings in metastatic melanoma treatment, where the drugs were already approved.

Eric Ducournau, CEO of Pierre Fabre Laboratories, expressed his satisfaction with the approval, stating, “We are pleased to be able to extend this treatment in Europe. There are currently limited targeted treatment options for BRAFV600E 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 PHAROS trial, a non-randomised, open-label study, enrolled 98 patients across multiple international sites. Results from the trial at the primary analysis point showed that the therapy not only achieved high response rates but also maintained responses over time. For treatment-naïve patients, 64% sustained their response for at least 12 months with a median duration of response stretching to an impressive 40 months. Previously treated patients also showed substantial benefit, with 44% maintaining a response for over a year.

Núria Perez-Cullell, Head of Medical, Patient, and Consumer Affairs at Pierre Fabre Laboratories, highlighted the importance of this approval in meeting the needs of patients with BRAFV600E mutant advanced NSCLC. She also emphasised the ongoing collaboration with Pfizer, which has been pivotal in developing and delivering this treatment to the market.

Safety profiles from the trial were consistent with previous findings in metastatic melanoma, with the most common adverse events being nausea, diarrhea, fatigue, and vomiting. The therapy was generally well-tolerated, though serious events such as colitis and one report of grade 5 intracranial hemorrhage were noted.

The approval of BRAFTOVI® and MEKTOVI® in Europe follows their earlier endorsement by the U.S. Food and Drug Administration (FDA) for the same indication, reflecting a global recognition of their potential in treating this challenging cancer type.