Janssen has submitted an application to the European Medicines Agency (EMA) to extend the marketing authorisation for daratumumab (Darzalex®) to include its use in combination with bortezomib (Velcade®), melphalan and prednisone as a treatment for newly diagnosed myeloma patients who are ineligible for an autologous stem cell transplant (ASCT).

This decision is based on the results from the Phase III ALCYONE trial which showed that the addition of daratumumab to bortezomib, melphalan and prednisone decreased the risk of disease progression and death by 50% in newly diagnosed patients.

Daratumumab is currently authorised by the EMA as a treatment for relapsed and refractory myeloma patients, both as a monotherapy, and in combination with lenalidomide (Revlimid®) and dexamethasone, or bortezomib and dexamethasone. This application therefore has the potential make daratumumab available to another group of myeloma patients.

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