EMA committee gives green light for daratumumab in newly diagnosed myeloma

Daratumumab (Darzalex®), an immunotherapy drug for the treatment of myeloma, has received a positive recommendation by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The recommendation relates to daratumumab in combination with bortezomib (Velcade®), melphalan and prednisolone (D-VMP) in the treatment of newly diagnosed myeloma patients who are ineligible for high-dose therapy and stem cell transplantation (HDT-SCT).

The decision means that daratumumab is one step closer to receiving marketing authorisation (a “license”) in Europe for newly diagnosed myeloma patients. Myeloma Patients Europe Chief Executive Ananda Plate commented:

“This is good news for myeloma patients in Europe. Data on daratumumab shows  it is a very effective drug for use in all stages of myeloma and it is positive that further treatment options are becoming available for newly diagnosed patients who cannot have a stem cell transplant. At MPE, we’ll be following the progress of daratumumab through the EMA and working with our members to help preparations for seeking national access.”

The CHMP is the scientific committee within the EMA, the drug licensing body in Europe. The CHMP assessed the safety and efficacy of daratumumab and made a recommendation to the European Commission on whether it should be granted marketing authorisation.

The European Commission now has 60 days to assess the recommendation and reach a final decision on whether daratumumab should be made available to patients. European marketing authorisation means that a drug is safe and effective for doctors to prescribe in patients, however, final availability for European patients rests on national funding decisions.

About daratumumab

Daratumumab is from a group of immunotherapy drugs known as monoclonal antibodies. It specifically targets a protein, known as CD38, which is expressed on the surface of myeloma cells. You can read the MPE Factsheet on daratumumab here.

The EMA application is based on data from a Phase III trial, known as the ALCYONE trial, which assessed D-VMP vs VMP alone in 706 newly diagnosed myeloma patients who were ineligible for HDT-SCT. The trial results found that the risk of progression in patients was reduced by 50% in the D-VMP arm.

Daratumumab currently has marketing authorisation from the EMA for use in relapsed myeloma, either as a monotherapy (e.g. prescribed on its own) or in combination with either bortezomib or lenalidomide and dexamethasone. The CHMP decisions means it is set to be licensed for use in all stages of myeloma.

Further information

Please email Kate Morgan, MPE Policy and Public Affairs Manager at if you have any further questions on the CHMP decision, daratumumab or on how medicines access works in Europe.