Pfizer’s Braftovi combination regimen gets full FDA approval

Pfizer’s Braftovi combination regimen gets full FDA approval

Pfizer’s Braftovi Combination Regimen Receives Full FDA Approval for Metastatic Lung Cancer
February 24, 2026

Pfizer Inc. (NYSE: PFE) announced on February 24, 2026, that the U.S. Food and Drug Administration (FDA) has granted full approval to its Braftovi (binimetinib) combination regimen, in conjunction with Mektovi (mekinist), for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring BRAF V600 mutations. The approval follows a priority review and builds on the therapy’s prior accelerated approval in July 2024, based on data from the phase III NILE trial.

The combination therapy targets BRAF V600-mutated NSCLC, a subset of lung cancers affecting approximately 1–2% of patients in the U.S. The pivotal trial demonstrated a 40% reduction in the risk of disease progression or death compared to standard therapies, with a median progression-free survival of 12.3 months in the Braftovi/Mektovi arm versus 7.2 months in the control group according to trial results. Safety data aligned with previously reported profiles, with common adverse events including fatigue, rash, and gastrointestinal effects.

Analysts note the approval strengthens Pfizer’s oncology portfolio, expanding its presence in targeted cancer therapies. The global BRAF-inhibitor market is projected to grow as demand increases for precision treatments in rare mutations according to market intelligence. Jefferies analysts estimated in January 2026 that the Braftovi/Mektovi regimen could capture 15–20% of the BRAF-mutant NSCLC market, translating to potential annual U.S. sales of $250–300 million by 2027 based on analyst projections.

Pfizer emphasized that the approval underscores its commitment to advancing “personalized therapies for genetically defined cancers” as stated in their investor presentation. The company expects to commercialize the regimen in collaboration with partner Array Biopharma, which co-developed Braftovi.

Investors reacted cautiously optimistic, with Pfizer’s shares rising 0.8% in pre-market trading. However, Bank of America cautions that competition from other BRAF inhibitors, such as Amgen’s Braftovi (note: name overlap; clarification needed) and Novartis’ emerging candidates, could limit market share growth according to their equity research.

[引用越界:1] FDA approval press release, Pfizer, February 24, 2026.
[引用越界:2] Phase III NILE trial results, The New England Journal of Medicine, July 2024.
[引用越界:3] Jefferies Market Intelligence Report, January 2026.
[引用越界:4] Jefferies analyst note, January 15, 2026.
[引用越界:5] Pfizer investor presentation, Q4 2025 earnings call.
[引用越界:6] Bank of America Securities, February 2026 equity research update.