Pierre Fabre Laboratories receives European Commission Approval for BRAFTOVI ...
The European Commission approved BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib) for advanced non-small cell lung cancer (NSCLC) with a BRAFV600E mutation, based on the Phase II PHAROS trial results showing a 75% objective response rate (ORR) in treatment-naïve patients and 46% in previously treated patients. The approval addresses limited targeted treatment options for BRAFV600E mutant NSCLC patients.
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Long-term Phase II PHAROS trial data show Pfizer’s Braftovi (encorafenib) and Mektovi (binimetinib) combo sustained efficacy in BRAF V600E-mutant metastatic NSCLC, positioning it as a promising first-line therapy. The combination demonstrated a 75% objective response rate (ORR) in treatment-naïve patients, with a median duration of response (DoR) of 40 months and median progression-free survival (PFS) of 30.2 months. Safety profile consistent with previous findings, with common treatment-related adverse events (TRAEs) including nausea, diarrhea, and fatigue. The combo was approved by the FDA in October 2023 and the European Commission in August 2024.
The European Commission approved BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib) for advanced non-small cell lung cancer (NSCLC) with a BRAFV600E mutation, based on the Phase II PHAROS trial results showing a 75% objective response rate (ORR) in treatment-naïve patients and 46% in previously treated patients. The approval addresses limited targeted treatment options for BRAFV600E mutant NSCLC patients.