Binimetinib Market Update 2026

On October 12, 2023, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Encorafenib in combination with Binimetinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring a BRAF V600E mutation, as detected by an FDA-approved test. The BRAF V600E mutation can be assessed in either plasma or tumor tissue using FDA-approved companion diagnostic tests, FoundationOne Liquid CDx (for plasma) and FoundationOne CDx (for tumor tissue), respectively.

"Today's approval underscores our long-standing commitment to delivering innovative, personalized cancer medicines to people living with lung cancer. By developing precision medicines for a patient’s specific cancer type, we are leveraging our deep understanding of tumor biology to help address the underlying cause of the disease," said Chris Boshoff, M.D., Ph.D., Chief Oncology Research and Development Officer and Executive Vice President at Pfizer. "Since its initial FDA approval in 2018, the Encorafenib and Binimetinib combination has helped thousands of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. We look forward to helping even more patients through this targeted combination regimen with today’s approval."

"A BRAF V600E mutation defines a distinct subtype of metastatic non-small cell lung cancer and represents an actionable biomarker that can be specifically targeted with precision medicines like Encorafenib and Binimetinib," said Gregory Riely, M.D., Ph.D., Vice Chair for Clinical Research in the Department of Medicine at Memorial Sloan Kettering Cancer Center (MSK) and a PHAROS trial investigator. "The PHAROS trial demonstrated the benefit patients with this alteration receive from targeted treatment with Encorafenib plus Binimetinib, regardless of their prior treatment history. Given the specific efficacy and safety profile, patients and providers now have an additional choice to tailor therapy based on individual risk factors and preferences."

About BRAF V600E-mutant Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the second most common cancer and the leading cause of cancer-related death globally. Non-small cell lung cancer accounts for approximately 80-85% of all lung cancers.

Certain lung cancers are associated with acquired genetic abnormalities, such as the BRAF V600E mutation. By using biomarkers to identify a patient's specific tumor type, treatment can become more personalized and effective, as the molecular makeup of one's cancer often determines how they will respond to different therapies.

The BRAF V600E mutation is found in approximately 2% of non-small cell lung cancer cases. It stimulates the growth and proliferation of tumor cells by altering the MAP kinase (MAPK) signaling pathway. Targeting components of this pathway may help inhibit the growth and proliferation of tumors driven by BRAF mutations.

Precision medicine is increasingly being developed for patients with NSCLC who have biomarker-detectable genetic alterations, such as BRAF mutations. In recent years, broader utilization of biomarker testing and targeted therapies has been associated with a reduction in NSCLC mortality at the population level.