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FDA approves Pfizer's Braftovi plus Mektovi for a type of non-small cell lung cancer

Pfizer Inc. (PFE) said Thursday the U.S. Food and Drug Administration has approved its Braftovi plus Mektovi combination therapy as a treatment for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. That mutation can be assessed from plasma or tumor tissue using an FDA-approved test. The approval is based on data from a Phase 2 clinical trial dubbed Pharos that is ongoing. "BRAF V600E mutations identify a unique subtype of metastatic non-small cell lung cancer that presents an actionable biomarker that precision medicines like BRAFTOVI + MEKTOVI combination therapy can help address," said Dr. Gregory Riely, vice chair, clinical research at Memorial Sloan Kettering Cancer Center and a Pharos researcher. The combination therapy is already approved for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Pfizer has the rights to Braftovi and Mektovi in the U.S., Canada and Latin America, Africa and the Middle East. Ono Pharmaceutical Co. Ltd. (JP:4528) has exclusive rights to commercialize both products in Japan and South Korea, Medison has exclusive rights in Israel, and Pierre Fabre has exclusive rights in all other countries, including Europe and Asia-Pacific (excluding Japan and South Korea). Pfizer's stock was up 0.4% premarket but has fallen 35% in the year to date, while the S&P 500 has gained 14%.

-Ciara Linnane

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10-12-23 0656ET

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