【FDA Approval Alert】Exelixis’s cabozantinib (Cabometyx) Approved for pNET and epNET (March 26, 2025)
On March 26, 2025, the U.S. FDA approved cabozantinib (Cabometyx) for adults and pediatric patients 12 years and older with previously treated unresectable or metastatic well-differentiated pancreatic neuroendocrine tumors (pNET) and extra-pancreatic neuroendocrine tumors (epNET). Approval was based on CABINET trial (NCT03375320).
Disease Overview: Pancreatic and Extra-Pancreatic Neuroendocrine Tumors (NET)
NETs are rare malignancies derived from hormone-producing cells. pNET and epNET have distinct clinical characteristics, and targeted therapies play a key role in managing advanced disease.
Treatment Summary
- Drug Name: cabozantinib (Cabometyx)
- Company: Exelixis, Inc.
- Approval Date: March 26, 2025
- Indication: Previously treated unresectable/metastatic pNET and epNET (adults and patients ≥12 years)
- Mechanism of Action: Multi-kinase inhibition (VEGFR, MET, AXL, etc.)
- Pivotal Trial: CABINET (NCT03375320)
- Key Efficacy:
- pNET cohort: Median PFS 13.8 vs 3.3 months (HR 0.22; p<0.0001), ORR 18% vs 0%
- epNET cohort: Median PFS 8.5 vs 4.2 months (HR 0.40; p<0.0001), ORR 5% vs 0%
Patient-Friendly Summary
Cabometyx is an oral multi-kinase inhibitor that blocks cancer growth pathways, offering a new option for patients with advanced pancreatic and extra-pancreatic NET.
M&A Information
- Subsidiary: Not applicable (Exelixis in-house development)
- Acquisition Date: Not applicable
- Development Stage at Acquisition: Not applicable
- Investor Information: Public Investors (NASDAQ: EXEL)
Source
This approval information is based on data from Drugs@FDA (U.S. FDA) and AACR releases.
