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FDA Approves Cabozantinib for Previously Treated Advanced Neuroendocrine Tumors

Medically reviewed by Carmen Pope, BPharm. Last updated on March 31, 2025.

By Stephanie Brown HealthDay Reporter

MONDAY, March 31, 2025 -- The U.S. Food and Drug Administration has approved cabozantinib (Cabometyx), an oral tyrosine kinase inhibitor, for patients with previously treated advanced neuroendocrine tumors, offering a new standard of care for this patient group, according to a press release from the Dana-Farber Cancer Institute.

The approval was based on the results of the phase 3 CABINET study, which compared cabozantinib to a placebo in patients with advanced pancreatic neuroendocrine tumors and advanced extrapancreatic neuroendocrine tumors who had previously undergone treatment. The results of the trial were published last September in the New England Journal of Medicine. Patients treated with cabozantinib survived significantly longer with no worsening of their disease compared with patients who received placebo. Given the improved efficacy observed in the interim analysis, the trial was terminated early and unblinded in August 2023.

The reported side effects of cabozantinib were similar to those found in other studies of the drug, including hypertension, fatigue, and diarrhea.

"Patients with neuroendocrine tumors often face a difficult journey," lead author of the CABINET study, Jennifer Chan, M.D., M.P.H., of the Dana-Farber Cancer Institute, said in a statement. "Despite advances in recent years, there has remained a critical need for new and effective therapies for patients whose cancer has grown or spread. Cabozantinib significantly improved outcomes in this patient population and this FDA approval provides new hope."

Approval of cabozantinib was granted to Exelixis.

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Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

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Posted March 2025

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