EU issues a positive opinion on Janssen’s Single-Agent

Janssen-Cilag International NV ("Janssen") announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending a conditional marketing authorization for first-in-class CD38 immunotherapy DARZALEX (daratumumab) in the European Union. The recommended indication is for monotherapy of adult patients with relapsed and refractory multiple myeloma (MM), whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. This application was reviewed under an accelerated assessment by the CHMP, a process reserved for medicinal products expected to be of major public health interest, particularly from the point of view of therapeutic innovation.