FDA Approves Pfizer’s Treatment for BRAF V600E-Mutant Non-Small Cell Lung Cancer

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This approval builds on a previous approval of the combination therapy for patients with BRAF V600E- or V600K-mutant unresectable or metastatic melanoma.

On Oct 12, 2023, Pfizer announced that FDA approved BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) to treat adults with metastatic non-small lung cancer (NSCLC) with a BRAF V600E mutation. BRAF V600E mutations can be found using plasma or tumor tissue with the FoundationOne Liquid CDx or the FoundationOne CDx FDA-approved companion diagnostic tests. BRAFTOVI + MEKTOVI combination therapy was previously approved by FDA in 2018 for patients with BRAF V600E- or V600K-mutant unresectable or metastatic melanoma.

This approval is predicated on data from the ongoing Phase II PHAROS clinical trial, which is an open-label, multicenter, single-arm study assessing the BRAFTOVI + MEKTOVI combination therapy in both new and previously treated patients with BRAF V600E-mutant metastatic NSCLC. NSCLC comprises 80–85% of all lung cancer, which is the second most common type of cancer and the leading cause of cancer-related deaths worldwide. Some lung cancers are linked to acquired genetic abnormalities, such as the BRAF V600E mutation, which occurs in around 2% of NSCLC cases. It aids tumor cell growth and spread by changing the MAP kinase signaling pathway. Precise targeting of this pathway’s components can potentially aid in inhibiting the tumor growth and spread caused by BRAF mutations.


“Today’s approval builds on our long-standing commitment to deliver innovative, personalized medicines to patients with lung cancer. By pursuing precision medicines that target a patient’s specific type of cancer, we are leveraging our deep understanding of tumor biology to help address the underlying cause of disease,” said Chris Boshoff, MD, PhD, Chief Oncology Research and Development Officer and Executive Vice President at Pfizer in a Pfizer press release. “Since its initial FDA approval in 2018, BRAFTOVI + MEKTOVI combination therapy has helped thousands of people living with BRAF V600E- or V600K-mutant unresectable or metastatic melanoma. We look forward to helping even more patients with our BRAFTOVI + MEKTOVI targeted combination therapy.”

Source: Pfizer