Supplemental BLA Submitted for Daratumumab Plus Hyaluronidase for MM

A supplemental Biologics License Application (BLA) was submitted to the US Food and Drug Administration (FDA) for the approval of daratumumab and hyaluronidase-fihj (DARZALEX FASPRO®) for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma, according to a press release by Johnson & Johnson, the manufacturer of the therapy.

According to results from the phase III PERSEUS trial, adding daratumumab and hyaluronidase-fihj to lenalidomide, bortezomib and dexamethasone induction and consolidation and lenalidomide maintenance therapy reduced the risk of progression or death by 58% compared with standard of care.

64% of patients who received the quadruplet therapy were able to discontinue treatment after achieving a complete response or measurable residual disease negativity after two years of lenalidomide maintenance.

“This regimen has the potential to improve long-term outcomes for newly diagnosed patients and we look forward to working with the FDA on the review of this application,” said Craig Tendler, MD, Vice President of Clinical Development, Diagnostics, and Global Medical Affairs at Johnson & Johnson Innovative Medicine, in the press release.