ARTICLE | Clinical News

Darzalex daratumumab regulatory update

October 17, 2016 7:00 AM UTC

FDA accepted for review an sBLA from Johnson & Johnson’s Janssen Biotech Inc. unit for Darzalex daratumumab plus dexamethasone and a third agent to treat multiple myeloma (MM). The combination plus either Revlimid lenalidomide or Velcade bortezomib is under Priority Review to treat patients who have received >=1 prior therapy; the PDUFA date is Feb. 17, 2017. The combination plus Pomalyst pomalidomide is under standard review to treat relapsed or refractory MM patients who have received >=2 prior therapies, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD); the PDUFA date is June 17, 2017. ...