Posted by Michael Wonder on 31 May 2019
U.S. FDA grants priority review for daratumumab in combination with bortezomib, thalidomide and dexamethasone in frontline multiple myeloma
30 May 2019 - 26 September 2019 PDUFA date.
Genmab announced today that the U.S. FDA granted a priority review for the supplemental biologics license application for the use of daratumumab (Darzalex) in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are candidates for autologous stem cell transplant.
The application was submitted by Genmab’s licensing partner Janssen in March 2019. The U.S. FDA assigned a Prescription Drug User Fee Act target date of 26 September 2019 to take a decision on daratumumab in this indication.
