On 24 March 2022, the European Medicines Agency’s (EMA’s) 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 cabozantinib (Cabometyx).

The marketing authorisation holder for this medicinal product is Ipsen Pharma.

The CHMP adopted a new indication for differentiated thyroid carcinoma (DTC).

The full indications for Cabometyx will therefore be as follows (new indication in bold):

Renal cell carcinoma (RCC)

Cabometyx is indicated as monotherapy for advanced RCC:

  • as first-line treatment of adult patients with intermediate or poor risk,
  • in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.

Cabometyx in combination with nivolumab, is indicated for the first-line treatment of advanced RCC in adults.

Hepatocellular carcinoma (HCC)

Cabometyx is indicated as monotherapy for the treatment of 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 DTC, refractory or not eligible to radioactive iodine who have progressed during or after prior systemic therapy.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.