Posted by Michael Wonder on 20 Jan 2018
U.S. FDA grants priority review for daratumumab in front line multiple myeloma
19 January 2018 - 21 May 2018 PDUFA date.
Genmab announced today that the U.S. FDA has granted priority review to the supplemental biologics license application for the use of daratumumab (Darzelex) 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 ASCT. The application was submitted by Genmab's licensing partner Janssen in November 2017.
The submission was based on data from the Phase III ALCYONE study of daratumumab in combination with bortezomib, melphalan and prednisone in front line multiple myeloma. This data was presented as a late-breaking abstract at the 2017 American Society of Hematology Annual Meeting and published in The New England Journal of Medicine in December, 2017.
