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FDA Approves Pfizer's Braftovi-Mektovi Combo, Foundation Medicine Tests for BRAF-Mutant NSCLC

NEW YORK – The US Food and Drug Administration on Wednesday approved Pfizer's Braftovi (encorafenib) plus Mektovi (binimetinib) for metastatic non-small cell lung cancer patients whose tumors harbor BRAF V600E mutations.

The FDA simultaneously approved Roche subsidiary Foundation Medicine's FoundationOne Liquid CDx or FoundationOne CDx as tests doctors can use to identify patients with BRAF V600E mutations eligible for Braftovi-Mektovi. The agency specified that if a mutation isn't detected with the liquid biopsy approach, then the tumor should be tested.

The approval is based on data from the ongoing Phase II PHAROS trial in which 98 patients with metastatic BRAF V600E-mutated NSCLC received Braftovi plus Mektovi. Among 59 patients who had not received prior treatment, the objective response rate was 75 percent, and among 39 patients who had received prior therapy, the objective response rate was 46 percent. The median duration of response was not yet reached in the treatment-naïve group and was 16.7 months in the previously treated group.

The FDA approved the BRAF/MEK inhibitor combination initially for treating advanced BRAF V600E- or BRAF V600K-mutated melanoma patients in 2018. Braftovi plus Eli Lilly's monoclonal antibody Erbitux (cetuximab) then garnered FDA approval for BRAF V600E-mutated advanced colorectal cancer patients in 2020.

Last year, the firm Erasca also announced that, together with Pierre Fabre, it would evaluate its Erk1/2 inhibitor ERAS-007 with Braftovi in BRAF V600E-mutated metastatic colorectal cancer.