ARTICLE | Clinical News

Daratumumab regulatory update

September 14, 2015 7:00 AM UTC

Johnson & Johnson submitted an MAA to EMA and FDA accepted and granted Priority Review to a BLA from the pharma for daratumumab to treat multiple myeloma (MM) patients who have received >=3 prior lines of therapy, including both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and an IMiD. The PDUFA date is March 9, 2016. The MAA submission triggered a $10 million milestone payment to Genmab from J&J under a 2012 deal granting the pharma’s Janssen Biotech Inc. unit exclusive, worldwide rights to the biotech’s human IgG1k mAb against CD38 (see BioCentury, Sept. 3, 2012). ...