In this article
FDA Approval of Encorafenib and Binimetinib for BRAF V600E NSCLC
The Food and Drug Administration (FDA) approved Encorafenib (Braftovi, Array BioPharma Inc., a wholly owned subsidiary of Pfizer) and binimetinib (Mektovi, Array BioPharma Inc.) in November 2023 as medicines that can be used to treat adults with metastatic non-small cell lung cancer (NSCLC) and a BRAF V600E mutation, which was found by an FDA-approved test.
The FDA also approved the FoundationOne CDx (tissue) and FoundationOne Liquid CDx (plasma) as companion diagnostics for encorafenib in conjunction with binimetinib. Testing of the tumour tissue is necessary if a plasma specimen does not reveal any mutations.
PHAROS Clinical Trial Efficacy and Results
The open-label, multicenter, single-arm PHAROS (NCT03915951) study looked at 98 people with metastatic NSCLC and the BRAF V600E mutation. The study’s effectiveness was tested on these people. Prior use of inhibitors of BRAF or MEK was prohibited. Encorafenib and binimetinib were administered to patients until disease progression or unacceptable toxicity occurred.
An independent review committee evaluated the duration of response (DoR) and objective response rate (ORR), which were the main indicators of effectiveness. The ORR was 75% (95% CI: 62, 85) among 59 treatment-naïve patients, while the median DoR was not estimable (NE) at 95% (95% CI: 23.1, NE). The ORR was 46% (95% CI: 30, 63) among 39 patients who had been treated previously, and the median DoR was 16.7 months (95% CI: 7.4, NE).
Adverse Effects and Dosage Guidelines
Fatigue, nausea, diarrhoea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnea, dermatitis, and cough were the most frequent adverse effects (25 percent or more).
For NSCLC mutated to BRAF V600E, the recommended oral doses of encorafenib 450 mg once daily and binimetinib 45 mg twice daily are administered.
How CancerFax Helps
CancerFax is a specialist cancer access and patient-navigation platform. We help patients and families understand their options, organise medical records, coordinate hospital communication, and support cross-border treatment planning where appropriate.
We help collect and organise reports, scans, pathology, biomarker results, and treatment history for structured case review.
We communicate with hospitals or trial teams to assess whether a case may be suitable for further screening.
We support appointment coordination, document submission, translation, and direct communication with international departments.
For international patients, we help with practical coordination — travel planning, hospital admission guidance, and local support.
If this option is not suitable, we help explore other relevant treatments, clinical trials, or advanced care pathways.
From inquiry through to follow-up, our coordinators provide a single point of contact for the family.
CancerFax does not guarantee treatment access, eligibility, or clinical outcome. Our role is to help patients access accurate information, structured review, and appropriate specialist pathways.
About Dr. Nishant Mittal
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. Significant contributions to stem cell biology, developmental biology, and innovative research techniques mark his career. Research Highlights Dr. Mittal's research has focused on several key areas: 1) Cardio…
✓ Reviewed for medical accuracy by the CancerFax review panel.
Medical Disclaimer
This article is for educational purposes only and should not replace medical advice, diagnosis, or treatment from a qualified oncology specialist. Every patient's case is different. Treatment decisions should always be made after a review of complete medical records by the treating medical team.
Treatment availability, eligibility, timelines, and access can change. Any clinical trial participation depends on detailed review and approval by the trial hospital or investigator.