On 19 June 2025, the European Medicines Agency’s (EMA) CHMP gave a positive opinion to extend the approved uses of cabozantinib (Cabometyx). The new recommendation covers adult patients with unresectable or metastatic, well differentiated extra-pancreatic and pancreatic neuroendocrine tumours (NETs) after prior systemic therapy other than somatostatin analogues.

New Indication for NETs

The update allows cabozantinib to treat adults with advanced extra-pancreatic and pancreatic NETs that have progressed after at least one prior systemic treatment. These patients often have limited options after first-line therapy, so this approval provides a new alternative for disease control.

Current Approved Uses

Cabozantinib is already approved in Europe for several cancers:

Renal Cell Carcinoma (RCC): As monotherapy for advanced RCC in intermediate/poor risk patients, or after VEGF-targeted therapy. Also, in combination with nivolumab for first-line treatment.

Hepatocellular Carcinoma (HCC): For adults previously treated with sorafenib.

Differentiated Thyroid Carcinoma (DTC): For adults with advanced DTC refractory to radioactive iodine and who progressed after systemic therapy.

Next Steps

The European Commission will review this recommendation. A final decision is usually made about 67 days after CHMP adoption. The updated summary of product characteristics will be published on the EMA website once approved.

This extension offers a new treatment option for NET patients with progressive disease after standard therapies. It also strengthens cabozantinib’s position as a multi-indication targeted therapy for several advanced cancers.