FDA OKs Encorafenib/Binimetinib in BRAF V600E+ Metastatic NSCLC

News
Article

Patients diagnosed with BRAF V600E–mutant, metastatic non–small cell lung cancer are now able to undergo treatment with combination encorafenib and binimetinib.

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 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
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