Darzalex's latest approval to trigger Genmab milestones

FDA approved Darzalex daratumumab from Johnson & Johnson (NYSE:JNJ) and Genmab A/S (CSE:GEN) in combination with Pomalyst pomalidomide and dexamethasone to treat multiple myeloma (MM) in patients who have received at least two prior therapies including Revlimid lenalidomide and a proteasome inhibitor (PI). The approval and expected first sale in the new indication are to trigger $25 million in milestone payments to Genmab from J&J.

The agency had already approved Darzalex in combination with dexamethasone plus Revlimid or Velcade bortezomib to treat MM in a second-line setting, and as monotherapy in either a fourth-line setting following a PI and an immunomodulatory agent, or in patients who are double-refractory to treatment with a PI or an immunomodulatory agent. It is the first mAb FDA has approved to treat MM...