Genmab and Janssen have announced that the European Commission has granted full approval for daratumumab (Darzalex®) to be used in combination with lenalidomide (Revlimid®) and dexamethasone, or bortezomib (Velcade®) and dexamethasome as a treatment for relapsed and/or refractory myeloma patients. This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use’s (CHMP) recommendation to approve these daratumumab combination based on data from the Phase III POLLUX and CASTOR trials and from two earlier stage trials MMY-1001 and GEN-503. Daratumumab was previously only licensed for use as a monotherapy.

 

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