Darzalex daratumumab regulatory update

FDA granted accelerated approval to Darzalex daratumumab from Johnson & Johnson’s Janssen Biotech Inc. unit to treat multiple myeloma (MM) in patients who have received >=3 prior therapies, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double-refractory to a PI and an IMiD. The approval comes about 4 months ahead of the drug’s PDUFA date of March 9, 2016 (see BioCentury, Sept. 14).

J&J launched Darzalex at an average wholesale acquisition cost (WAC) of $5,850 per infusion, based on a 176-pound patient. The cost would be $134,550 for the first year of treatment and $76,050 for the second year. The first commercial sale of Darzalex in the U.S. triggered a $45 milestone payment to Genmab from Janssen under a 2012 deal granting Janssen exclusive, worldwide rights to the human IgG1k mAb against CD38 (see BioCentury, Sept. 3, 2012). ...