US EditionFDA Approves Cabozantinib for Previously Treated Advanced Neuroendocrine Tumors
- On March 26, 2025, the FDA approved Cabometyx for patients ages 12 and older with previously treated, unresectable locally advanced or metastatic, well-differentiated pancreatic and extra-pancreatic neuroendocrine tumors.
- This approval was based on positive results from the Phase 3 CABINET trial , which compared cabozantinib to a placebo in patients with advanced pancreatic and extra-pancreatic neuroendocrine tumors who had previously undergone treatment, and was published in the New England Journal of Medicine last September.
- The CABINET trial showed that patients treated with Cabometyx experienced a median progression-free survival of 13.8 months in pancreatic NET and 8.5 months in extra-pancreatic NET, while those receiving placebo had a median progression-free survival of 3.3 months and 4.2 months, respectively.
- Key data from the pNET cohort include a hazard ratio for PFS of 0.22 , and approval of cabozantinib was granted to Exelixis.
- The FDA approval offers a new standard of care for this patient group, addressing a critical need for new and effective therapies, as noted by Jennifer Chan, MD, MPH, from the Dana-Farber Cancer Institute, who stated that cabozantinib provides new hope and an effective tool for disease management in this challenging patient population.
21 Articles
21 Articles
FDA approves cabozantinib for previously treated advanced neuroendocrine tumors
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.
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FDA Approves Cabozantinib for Previously Treated Advanced Neuroendocrine Tumors
MONDAY, March 31, 2025 (HealthDay News) -- 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,…
FDA Approves Cabozantinib for Adults and Pediatric Patients 12 Years of Age and Older with pNET and epNET
The FDA approved cabozantinib for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET). [FDA] Press Release
FDA Approves New Treatment for PNETs: What You Need to Know
Mar 31, 2025 - By Erin PostThe U.S. Food & Drug Administration has granted approval for a new drug to treat pancreatic neuroendocrine tumors, also called PNET or PanNET. “I am delighted that patients with pancreatic neuroendocrine tumors now have another treatment option,” said PanCAN Chief Scientific and Medical Officer Anna Berkenblit, MD, MMSc. “While PNETs tend to grow more slowly than the most common type of pancreatic cancer, called pancre…
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