FDA OKs Encorafenib/Binimetinib in BRAF V600E+ Metastatic NSCLC

The approval of encorafenib and binimetinib in BRAF V600E–mutant, metastatic non–small cell lung cancer was backed by data from the phase 2 PHAROS study.

The FDA has granted approval to encorafenib (Braftovi) and binimetinib (Mektovi) for the treatment of adult patients diagnosed with metastatic non–small cell lung cancer (NSCLC) harboring a BRAF V600E mutation as detected via an FDA-approved test, according to a press release from the FDA.¹

Supporting data came from the phase 2 PHAROS study (NCT03915951), which included 98 patients with metastatic, BRAF V600E–mutant disease. Investigators reported an overall response rate (ORR) of 75% (95% CI, 62%-85%) in the treatment naïve cohort (n = 59). Moreover, the median duration of response (DOR) in this group was not estimable (NE; 95% CI, 23.1 months to NE). In those who previously received treatment (n = 39), the ORR was 46% (95% CI, 30%-63%), with a median DOR of 16.7 months (95% CI, 7.4-NE).

Frequently occurring toxicities included fatigue, nausea, diarrhea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnea, rash, and cough.

TheFDA accepted a supplemental new drug application for encorafenib and binimetinib in BRAF V600E–mutant, metastatic NSCLC in April 2023.²

References

1. FDA approves encorafenib with binimetinib for metastatic non-small cell lung cancer with a BRAF V600E mutation. News release. FDA. October 11, 2023. Accessed October 11, 2023. https://bit.ly/46sC1iW
2. FDA accepts Pfizer’s supplemental new drug applications for Braftovi + Mektovi. News release. Pfizer. April 4, 2023. Accessed October 11, 2023. bit.ly/40KoC2S