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Pierre Fabre Seeking European Approval for Braftovi-Mektovi in BRAF-Mutated NSCLC

NEW YORK – Pierre Fabre Laboratories said on Thursday that it has filed for European approval for Braftovi (encorafenib) plus Mektovi (binimetinib) in advanced, BRAF V600-mutated non-small cell lung cancer.

The European Medicines Agency has validated the application, which is based on the results of the ongoing Phase II PHAROS clinical trial. In that study, 98 patients with metastatic BRAF V600E-mutated NSCLC received the Braftovi-Mektovi combination, yielding an objective response rate of 75 percent among those who were treatment-naïve. For patients who had received prior therapy, the objective response rate was 46 percent.

Last month, the US Food and Drug Administration approved Braftovi and Mektovi — which are Pfizer-owned products in the US and Canada — for metastatic, BRAF V600E-mutated NSCLC.

At the same time, the FDA approved Roche subsidiary Foundation Medicine's FoundationOne Liquid CDx or FoundationOne CDx as tests to identify patients eligible for the treatment combo.

Braftovi and Mektovi are approved in Europe and the US for advanced BRAF V600-mutated melanoma patients.