Posted by Michael Wonder on 08 May 2018
Genmab announces U.S. FDA approval of Darzalex (daratumumab) in newly diagnosed multiple myeloma
7 May 2018 - First approval for Darzalex in a frontline indication.
Genmab announced today that the U.S. FDA has approved the use of Darzalex (daratumumab) in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The supplemental biologics license application for this indication was submitted by Genmab’s licensing partner Janssen in November 2017. The U.S. FDA subsequently granted priority review to the application, with a PDUFA target date of 21 May 2018.
