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Daratumumab (Darzalex®), an immunotherapy drug for the treatment of myeloma, has been granted marketing authorisation (e.g. a licence) by the European Commission. It is specifically licensed for use in combination with bortezomib (Velcade®), melphalan and prednisolone (D-VMP) in newly diagnosed myeloma patients who are ineligible for high-dose therapy and autologous stem cell transplantation.

The decision means that daratumumab is effective for use in myeloma patients in this setting and that doctors can safely prescribe it for patients. However, in most European countries, for patients to receive a new drug it needs to have funding approved by the national healthcare system. In many cases, healthcare systems use a process called health technology assessment (HTA) to determine whether to fund a new drug. You can read about this here.

It is anticipated that there may be challenges in seeking national approval for D-VMP in the newly diagnosed setting, particularly given that it is one of the first four-drug treatment combinations approved in Europe for myeloma. MPE will be working with members, clinical advisors and the relevant pharmaceutical company to anticipate any challenges and to help seek national access across Europe.

The European Commission decision follows recent approval from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee within the European Medicines Agency (EMA). The CHMP assessed the safety and efficacy of daratumumab and made a positive recommendation to the European Commission indicating that it should approve the medicine for patients.

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 European Commission means that it is now licensed for use in all stages of myeloma.

Further information

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

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