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FDA approves Darzalex for MM

November 17, 2015 2:33 AM UTC

FDA granted accelerated approval to Darzalex daratumumab from the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ) and Genmab A/S (CSE:GEN; Pink:GMXAY) to treat multiple myeloma. The agency approved the human IgG1k mAb against CD38 to treat MM patients who have received at least three prior therapies, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.

The approval is the first for a monoclonal antibody to treat MM, and was based on open-label studies. The drug has been available since July under a compassionate use program; J&J intends to continue to make Darzalex available under the program in territories where it has not yet been approved (see BioCentury, Nov. 16). ...