The US Food and Drug Administration (FDA) has granted priority review to the supplemental biologics licence application (sBLA) for the use of daratumumab in front line multiple myeloma.
Review
Janssen Biotech, Genmab’s licensing partner, submitted the sBLA in November last year (2017), which specified the use of daratumumab (DARZALEX) 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). Priority review is assigned by the FDA for treatments that are used for a serious condition and may provide a significant improvement in safety or efficacy. The agency has assigned a prescription drug user fee act (PDUFA) target date of 21 May to make a decision on this proposed indication for daratumumab.
“The granting of priority review to the submission of daratumumab in front line multiple myeloma is an important step forward towards potentially bringing this product to an even larger number of patients in need,” said Jan van de Winkel, PhD, chief executive officer of Genmab.
Submission of the sBLA has been based on the Phase III ALCYONE study, the data of which was presented as a late-breaking abstract at the 2017 American Society of Hematology (ASH) annual meeting.