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FDA 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.

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Morgan County Citizen

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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,…

2 days ago·Madison, United States

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Stemwell Science News

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

8 hours ago

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targetedonc.com

Efficacy and Safety Outcomes Support Approval of Cabozantinib in NETs

Jennifer Chan, MD, MPH, discussed the findings from the phase 3 CABINET trial leading to the FDA approval of cabozantinib in patients with neuroendocrine tumors.

2 days ago

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Pancreatic Cancer Action Network

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…

2 days ago

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Medical Xpress

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.

2 days ago

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onclive.com

Dr Chan on the FDA Approval of Cabozantinib for Pancreatic and Extra-Pancreatic Neuroendocrine Tumors

Jennifer Chan, MD, MPH, discusses the FDA approval of cabozantinib for previously treated, advanced well-differentiated (extra) pancreatic neuroendocrine tumors.

5 days ago

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