FDA Approves Encorafenib/Binimetinib for BRAF V600E+ NSCLC

FDA Approves Encorafenib/Binimetinib for BRAF V600E NSCLC

The FDA approved encorafenib (Braftovi) plus binimetinib (Mektovi) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation detected by a test also approved by the Agency.

In addition, the FDA approved FoundationOne Liquid CDx (plasma) and FoundationOne CDx (tissue) as companion diagnostics for both encorafenib and binimetinib, according to a statement from the agency. If a plasma specimen does not detect a mutation, the agency suggested testing the tumor tissue.

The FDA approval of encorafenib and binimetinib was based on findings from the PHAROS study (NCT03915951), an open-label, multicenter, single-arm study that excluded patients with metastatic NSCLC previously treated with BRAF or MEK inhibitors. Patients in this study were treated with encorafenib plus binimetinib until unacceptable toxicity or disease progression.

The major efficacy outcome that researchers measured was objective response rate (ORR) per RECIST v1.1, in addition to duration of response (DOR), which was assessed by an independent review committee, according to the release.

Of the 59 treatment-naïve patients with metastatic NSCLC in this study, the ORR was 75% (95% CI, 62-85). In addition, the median DOR was not estimable (95% CI, 23.1-not estimable).

In the treatment naïve population (n = 39), the ORR was 46% (95% CI, 30-63), and the median DOR was 16.7 months (95% CI, 7.4-not estimable).

The recommended starting dose for patients with NSCLC is 450 mg of encorafenib and 45 mg of binimetinib once daily. Both of these medications are oral drugs. Encorafenib can be taken with or without food.

In the trial, over 25% of patients reported fatigue, nausea, diarrhea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnea, rash, and cough, all of which were the most commonly reported toxicities.

The prescribing label for encorafenib lists certain warnings with the medication. Nurses should advise patients to report any new heart, liver, bleeding, or eye problems. This can include feeling a shortness of breath or racing heart, swelling in the extremities, yellowing of skin or eyes, tea-colored urine, vomiting blood or vomit that looks like “coffee grounds,” red or black stool, or blurry vision.

References

1. FDA approves encorafenib with binimetinib for metastatic non-small cell lung cancer with a BRAF V600E mutation. FDA. October 11, 2023. Accessed October 11, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-encorafenib-binimetinib-metastatic-non-small-cell-lung-cancer-braf-v600e-mutation
2. Encorafenib (Braftovi); Prescribing information. Pfizer Inc. Updated October 2023. Accessed October 11, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210496s014lbl.pdf