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.[1-3] The safety profile is consistent with that observed in the approved metastatic melanoma indication.[1]
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)

CASTRES, France, Aug. 30, 2024 /PRNewswire/ -- Pierre Fabre Laboratories announced today 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 BRAFV600E 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 BRAFV600E mutant metastatic NSCLC.[1]

"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 BRAFV600E mutation in Europe" said Eric Ducournau, Chief Executive Officer of Pierre Fabre Laboratories. "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 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.[1-3] 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]).[2,3]*

CONTACT: Laurence MARCHAL, laurence.marchal@pierre-fabre.com

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