NEW YORK – The European Commission has approved Pfizer's Braftovi (encorafenib) and Mektovi (binimetinib), commercialized in Europe by Pierre Fabre Laboratories, for the treatment of patients with advanced non-small cell lung cancer with a BRAF V600E mutation.
The approval was based on primary results from the Phase II PHAROS trial, in which the Braftovi-Mektovi combination demonstrated an objective response rate of 75 percent in treatment-naïve NSCLC patients and 46 percent in previously treated NSCLC patients. An updated analysis of the PHAROS trial with additional follow-up showed that 64 percent of patients maintained a response for at least 12 months and that the median duration of response was 40 months on Braftovi-Mektovi.
Last year, the US Food and Drug Administration approved Braftovi and Mektovi in a similar indication for metastatic non-small cell lung cancer patients whose tumors harbor BRAF V600E mutations. The FDA concurrently approved Foundation Medicine's FoundationOne Liquid CDx or FoundationOne CDx assay as a companion diagnostic to identify NSCLC patients with BRAF V600E mutations.
In Europe, the Braftovi-Mektovi combination is also approved for patients with BRAF V600E-mutant unresectable or metastatic melanoma. Braftovi is also approved in Europe in combination with Eli Lilly's monoclonal antibody Erbitux (cetuximab) for previously treated BRAF V600E-mutant metastatic colorectal cancer.