FDA approves Cabometyx for advanced neuroendocrine tumors

26 March 2025

US biotech Exelixis (Nasdaq: EXEL) has secured a sixth indication for its cancer drug Cabometyx (cabozantinib), following a green light from the Food and Drug Administration for advanced neuroendocrine tumors (NET).

Cabometyx is now the first targeted therapy specifically cleared for NET patients across a broad population, regardless of the primary tumor location, tumor grade, or somatostatin receptor expression. The decision follows positive data from the Phase III Cabinet study.

In a statement, Exelixis’ chief medical officer Amy Peterson said the company is “doubling down” on its commitment to NET, and plans to launch a follow-up trial, Stellar-311, testing its next-generation drug zanzalintinib against Novartis’ (NOVN: VX) Afinitor (everolimus) in the first half of 2025.

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