ARTICLE | Company News

Darzalex under FDA review for second-line MM

October 7, 2016 7:00 AM UTC

Genmab A/S (CSE:GEN) said FDA granted Priority Review to an sBLA for Darzalex daratumumab in combination with Revlimid lenalidomide or Velcade bortezomib and dexamethasone to treat multiple myeloma in patients who have received at least one prior therapy. The PDUFA date is Feb. 17, 2017.

Genmab said FDA also granted standard review to the human IgG1k mAb against CD38 in combination with Pomalyst pomalidomide and dexamethasone in third-line MM patients previously treated with a PI therapy and an immunomodulatory agent. The PDUFA date in that indication is June 17, 2017. ...