FDA Accepts SNDAs For Pfizer’s BRAFTOVI + MEKTOVI

(RTTNews) – Pfizer Inc. (PFE) Tuesday said the Food and Drug Administration accepted Supplemental New Drug Applications (sNDAs) for BRAFTOVI plus MEKTOVI for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation.

A decision by the FDA on the SNDAs is expected in the fourth quarter.

The sNDAs are supported by results from the Phase 2 PHAROS study evaluating BRAFTOVI in combination with MEKTOVI in patients with BRAF V600E-mutant metastatic NSCLC.

In the U.S., BRAFTOVI + MEKTOVI is currently approved for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. BRAFTOVI is also approved in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation.

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