On October 12, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved cannefenib in combination with bimetinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) confirmed by an FDA-approved test to harbor the BRAF V600E mutation. The BRAF V600E mutation can be assessed from plasma or tumor tissue using FDA-approved companion diagnostic tests, FoundationOneLiquidCDx (for plasma) and FoundationOneCDx (for tumor tissue), respectively.
“Today’s approval underscores our long-standing commitment to providing innovative, personalized medicines for lung cancer patients. By developing precision medicines that target specific cancer types, we are leveraging our deep understanding of tumor biology to help address the root causes of the disease,” said Chris Boschoff, MD, PhD, Chief Oncology Research Officer and Executive Vice President at Pfizer. “Since its initial FDA approval in 2018, the combination of cannefenib and bimetinib has helped thousands of patients with unresectable or metastatic melanoma harboring BRAF V600E or V600K mutations. We look forward to helping even more patients with this targeted combination therapy.”
BRAF “The V600E mutation marks a unique subtype of metastatic non-small cell lung cancer (NSCLC) and is an actionable biomarker that precision medicine therapies like cannefenib in combination with bimetinib can address this issue,” said Gregory Riley, MD, PhD, Vice Chair of Clinical Research at Memorial Sloan Kettering Cancer Center (MSK) and investigator of the PHAROS trial. “The PHAROS trial demonstrated that these patients benefit from targeted therapy with cannefenib in combination with bimetinib, regardless of their prior treatment history. Given its specific efficacy and safety profile, patients and healthcare professionals now have another option to personalize treatment plans 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 worldwide and the leading cause of cancer-related deaths. Non-small cell lung cancer accounts for approximately 80-85% of all lung cancers.
Some lung cancers are associated with acquired genetic abnormalities, such as the BRAF V600E mutation. By utilizing biomarkers to identify a patient's specific tumor type, treatment can become more personalized and effective, as the molecular makeup of an individual's cancer often determines their response to different therapies.
BRAF V600E mutations are found in approximately 2% of non-small cell lung cancer (NSCLC) cases. It stimulates tumor cell growth and proliferation by altering the MAP kinase (MAPK) signaling pathway. Targeting components of this pathway has the potential to help suppress tumor growth and proliferation caused by BRAF mutations.
Precision medicine is increasingly being developed for NSCLC patients with genetic alterations (such as BRAF mutations) that can be detected through biomarker testing. In recent years, the wider application of biomarker testing and targeted therapies has been associated with a reduction in population-level NSCLC mortality.
