FDA clears Exelixis’ TKI for neuroendocrine tumours

FDA Approves CABOMETYX for Advanced Neuroendocrine Tumors

The U.S. Food and Drug Administration (FDA) has approved CABOMETYX (cabozantinib) for the treatment of previously treated advanced neuroendocrine tumors (NETs) in patients 12 years and older13.

This approval covers both pancreatic NET (pNET) and extra-pancreatic NET (epNET), making CABOMETYX the first and only FDA-approved systemic treatment for previously treated NETs regardless of primary tumor site, grade, somatostatin receptor expression, and functional status15.

The approval is based on results from the phase 3 CABINET trial, which demonstrated significant improvement in progression-free survival compared to placebo5.

The National Comprehensive Cancer Network has updated its guidelines to include cabozantinib as a category 1 preferred regimen for well-differentiated advanced NET5.

CABOMETYX is an oral tyrosine kinase inhibitor (TKI) that targets multiple pathways involved in tumor growth and angiogenesis8.

This marks the sixth FDA-approved indication for CABOMETYX, expanding its use in oncology5.

The safety profile of CABOMETYX in NET patients was consistent with previous findings, though a higher incidence of hypertension was noted compared to other tumor types5.

Exelixis, the company behind CABOMETYX, is planning to initiate the STELLAR-311 pivotal trial examining zanzalintinib (another TKI) versus everolimus in NET patients5.

This FDA approval represents a significant advancement in the treatment of advanced neuroendocrine tumors, providing a new option for patients with limited therapeutic choices8.

Sources:

1. https://www.morningstar.com/news/dow-jones/202503266285/exelixis-gets-expanded-fda-approval-of-cabometyx-in-advanced-neuroendocrine-tumors

3. https://www.marketscreener.com/quote/stock/EXELIXIS-INC-9235/news/Exelixis-Gets-Expanded-FDA-Approval-of-Cabometyx-in-Advanced-Neuroendocrine-Tumors-49440195/

5. https://www.stocktitan.net/news/EXEL/exelixis-announces-u-s-fda-approval-of-cabometyx-cabozantinib-for-fiqhfb05r2ph.html

8. https://www.dana-farber.org/newsroom/news-releases/2025/fda-approves-dual-action-drug-for-patients-with-previously-treated-advanced-neuroendocrine-tumors-backed-by-dana-farber-research