EU approves Darzalex (daratumumab) plus lenalidomide and dexamethasone for multiple myeloma- Genmab
Genmab announced that the European Commission (EC) 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 EC approval follows a positive opinion issued for Darzalex by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in February 2017.
This approval also converts the previous conditional marketing authorization 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 commercialize the product.
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