European Commission validates submission for approval of encorafenib (Braftovi) and binimetinib (Mektovi) for the treatment of adult patients with BRAF V600–mutant advanced non–small cell lung cancer
The European Medicines Agency had validated the submission of a marketing authorization application (MAA) seeking the approval of the combination of encorafenib (Braftovi) and binimetinib (Mektovi) for the treatment of adult patients with BRAF V600–mutant advanced non–small cell lung cancer (NSCLC) who are treatment naïve or have received prior therapy
The MAA is supported by data from the phase II PHAROS trial (NCT03915951), which demonstrated that treatment-naïve patients who received the combination (n = 59) experienced an overall response rate (ORR) of 75% (95% CI, 62%-85%), including complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) rates of 15%, 59%, 17%, and 3%, respectively. Previously treated patients (n = 39) achieved an ORR of 46% (95% CI, 30%-63%), including CR, PR, SD, and PD rates of 10%, 36%, 33%, and 8%, respectively.
On October 11, 2023, the FDA approved encorafenib plus binimetinib for the treatment of adult patients with metastatic NSCLC harboring a BRAF V600E mutation, as detected by an FDA-approved test. That regulatory decision was also supported by data from PHAROS..
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