EMA Recommends Extension of Indications for Ipilimumab

New indication concerns combination with nivolumab for the treatment of advanced melanoma in adults

On 26 April 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 ipilimumab (Yervoy). 

The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG. 

The CHMP adopted a change to the existing indication as follows: 

  • Yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. 
  • Relative to nivolumab monotherapy, an increase in progression-free survival and overall survival for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression.   
  • For earlier recommended indication, the CHMP now specified that Yervoy as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults, and adolescents 12 years of age and older. 

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.