The positive CHMP opinion is based on results from the Phase II PHAROS trial,[1] which demonstrated 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[1] The European Commission decision for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) is expected later this year.
CASTRES, France, July 26, 2024 /PRNewswire/ — Pierre Fabre Laboratories announced today that the Committee for Medicinal Products for Human Use (CHMP) 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. The positive opinion will now be submitted to the European Commission (EC) with a decision on EU marketing authorisation (MA) expected later this year.
Eric Ducournau, Chief Executive Officer, Pierre Fabre Laboratories said: "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 at present 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 5 countries.[1]
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. 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% of them maintaining their response for at least 12 months. For those 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.[1]
CONTACT: Laurence MARCHAL laurence.marchal@pierre-fabre.com
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