Pfizer Inc (NYSE:PFE) announced that the United States Food and Drug Administration (FDA) has approved BRAFTOVI (encorafenib) plus MEKTOVI (binimetinib) for adult patients with metastatic non-small cell lung cancer, as detected by an FDA-approved test.
The pharmaceutical giant said the approval is based on data from its ongoing Phase 2 PHAROS trial which is examining BRAFTOVI plus MEKTOVI combination therapy in both treatment-naïve and previously treated patients with BRAF V600E-mutant metastatic non-small cell lung cancer.
"BRAF V600E mutations identify a unique subtype of metastatic non-small cell lung cancer that presents an actionable biomarker that precision medicines like BRAFTOVI plus MEKTOVI combination therapy can help address," PHAROS investigator Dr. Gregory Riely said in a statement.
"Given the specific efficacy and safety profile, patients and providers now have another option to help personalize treatment plans based on individual risk factors and preferences."
Pfizer noted that it has exclusive rights to BRAFTOVI and MEKTOVI in the United States, Canada, and all countries in Latin America, Africa, and the Middle East.
Pfizer shares traded modestly higher on the news, up 0.3% at US$33.20 in pre-market trading.
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