On 19 June 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Cabometyx. The marketing authorisation holder for this medicinal product is Ipsen Pharma.

The CHMP adopted a new indication as follows:

Neuroendocrine Tumours (NET)

Cabometyx is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.

For information, the full indications for Cabometyx will be as follows¹:

Renal cell carcinoma (RCC)

Cabometyx is indicated as monotherapy for advanced renal cell carcinoma

Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1).

Hepatocellular carcinoma (HCC)

Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.

Differentiated thyroid carcinoma (DTC)

Cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.

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Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Name of medicine

Cabometyx

EMA product number

EMEA/H/C/004163

Active substance

cabozantinib (s)-malate

International non-proprietary name (INN) or common name

cabozantinib

Therapeutic area (MeSH)

Anatomical therapeutical chemical (ATC) code

L01EX07

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Marketing authorisation holder

Ipsen Pharma

Date of opinion

Status

Positive