Genmab and Janssen have announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation to expand the existing market licence for daratumumab (Darzalex®) as a treatment for relapsed and/or refractory myeloma patients. Currently licensed as a monotherapy, the latest recommendation is for the use of daratumumab in combination with lenalidomide (Revlimid®) and dexamethasone, or bortezomib (Velcade®) and dexamethasone, in myeloma patients who have received at least one previous line of treatment based on data from the Phase III POLLUX and CASTOR trials. A final decision by the European Commission (EC) is expected within the next two months.


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