EMA Recommends Extensions of Indications for Cabozantinib

New indication concerns treatment-naive adults with intermediate or poor risk advanced RCC

On 22 March 2018, the European Medicines Agency (EMA) 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 an extension to the existing indication. New indication concerns the treatment-naive adults with intermediate or poor risk advanced renal cell carcinoma (RCC). 

Cabometyx is indicated for the treatment of advanced RCC: 

  • in treatment-naive adults with intermediate or poor risk 
  • in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy 

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. 

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