EMA Recommends a Change to the Terms of the Marketing Authorisation for Carfilzomib

EMA adopted an extension to the existing indication in patients with multiple myeloma

On 26 May 2016, 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 carfilzomib (Kyprolis).

The marketing authorisation holder for this medicinal product is Amgen Europe B.V.

The CHMP adopted an extension to the existing indication as follows:

“Kyprolis in combination with either lenalidomide and dexamethasone or dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior 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.