28 April 2017 - Darzalex approved in Europe in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone in patients who have received at least one prior therapy.

Genmab announced today that the European Commission has granted a marketing authorization for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. 

The European Commission approval follows a positive opinion issued for Darzalex by the CHMP of the EMA in February 2017. This approval also converts the previous conditional marketing authorisation for Darzalex to a full approval. 

Darzalex is being developed under an August 2012 agreement in which Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialise the product.

Read Genmab press release