FDA Accepts Supplemental New Drug Application for Encorafenib, Binimetinib Combination in NSCLC


The application is based on the PHAROS trial, which met its primary endpoint of objective response rate in patients with metastatic non–small cell lung cancer with a BRAF V600E mutation.

Officials with the FDA have accepted a supplemental New Drug Application from Pfizer for the combination of encorafenib (Braftovi) and binimetinib (Mektovi) in patients with metastatic non–small cell lung cancer (NSCLC) with a BRAF V600E mutation.

A Prescription Drug User Fee Act goal date has been set for the fourth quarter of 2023. The combination is currently approved for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Encorafenib is also approved in combination with cetuximab for the treatment of adults with metastatic colorectal cancer with a BRAF V600E mutation after prior therapy.

Lung cancer is the second most common type of cancer and the number 1 cause of cancer-related death globally. In 2023, the American Cancer Society estimates that there will be approximately 238,340 new cases of lung cancer diagnosed in the United States, and NSCLC accounts for between 80% and 85% of all lung cancers.

Some lung cancers are associated with acquired genetic abnormalities. For example, a BRAF V600E mutation occurs in approximately 2% of NSCLC cases and stimulates tumor cell growth and proliferation by altering the MAP kinase signaling pathway. Targeting components of this pathway could potentially inhibit unchecked tumor growth and proliferation caused by BRAF mutations, according to Pfizer.

Precision medicine is increasingly targeting patients with NSCLC and genetic changes, such as BRAF mutations, which can be detected using biomarker tests. Advances in targeted therapy have been associated with significant improvements in population-level NSCLC mortality in recent years.

“Since their initial regulatory approvals, Braftovi and Mektovi have helped improve outcomes in their respective indications of BRAF-mutated metastatic melanoma and BRAF-mutated metastatic colorectal cancer,” said Chris Boshoff, MD, PhD, chief development officer of oncology and rare disease at Pfizer Global Product Development, in a press release. “Through our comprehensive development program, the Braftovi and Mektovi combination has shown the potential to help more patients, such as those living with BRAF V600E-mutant non–small cell lung cancer.”

The applications are supported by results from the PHAROS trial, an open-label, multicenter, non-randomized, phase 2 study to determine the safety, tolerability, and efficacy of encorafenib in combination with binimetinib in patients with BRAF V600E-mutant NSCLC. The trial met its primary endpoint of objective response rate and detailed results will be presented at an upcoming scientific congress. Secondary objectives will evaluate additional efficacy endpoints and safety, including duration of response.

Encorafenib is an oral small molecule BRAF kinase inhibitor and binimetinib is an oral small molecule MEK inhibitor targeting key proteins in the MAP kinase signaling pathway. Inappropriate activation of this pathway has been shown to occur in many cancers, including melanoma, metastatic colorectal cancer, and NSCLC.


FDA Accepts Pfizer’s Supplemental New Drug Applications for Braftovi + Mektovi. News release. Pfizer; April 4, 2023. Accessed April 5, 2023. https://www.pfizer.com/news/press-release/press-release-detail/fda-accepts-pfizers-supplemental-new-drug-applications

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