EU CHMP recommends broadening approval of Darzalex (daratumumab) for multiple myeloma- Janssen-Cilaq
Janssen-Cilag International NV announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorisation for Darzalex (daratumumab). If approved by the European Commission, daratumumab can be used in combination with lenalidomide and dexamethasone; or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.
The Positive Opinion of the CHMP was based on a review of data from the Phase III MMY3003 (POLLUX) study, published in The New England Journal of Medicine in October 2016 and the Phase III MMY3004 (CASTOR) study, also published in The New England Journal of Medicine in August 2016. The safety profile of daratumumab in combination with standard-of-care regimens was consistent with monotherapy studies. In combination with lenalidomide, and dexamethasone (POLLUX) the most common adverse events of grade 3 or 4 during treatment were neutropenia (51.9%), thrombocytopenia (12.7%), and anaemia (12.4%).
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