EMA Recommends Extension of Therapeutic Indications for Cabozantinib

New indication concerns the treatment of hepatocellular carcinoma in adults who have previously been treated with sorafenib
26 Sep 2018
Gastrointestinal cancers;  Anticancer agents & Biologic therapy

On 20 September 2018, 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 as follows: Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma in adults who have previously been treated with sorafenib

For information, the full indications for Cabometyx will be as follows

Renal cell carcinoma 

Cabometyx is indicated for the treatment of advanced renal cell carcinoma: 

  • in treatment-naïve adults with intermediate or poor risk
  • in adults following prior vascular endothelial growth factor-targeted therapy
Hepatocellular carcinoma 

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

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 adoption of the opinion.

Last update: 26 Sep 2018

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