Supplemental BLA Submitted for MM Treatment Combination

A supplemental Biologics License Application (BLA) was submitted to the US Food and Drug Administration (FDA) for the approval of a new indication for daratumumab and hyaluronidase-fihj (DARZALEX FASPRO®) combined with D-VRd (bortezomib, lenalidomide, and dexamethasone) for transplant-ineligible, newly diagnosed multiple myeloma (MM), according to a press release by Johnson & Johnson, the manufacturer of the therapy. The combination was previously indicated for transplant-eligible patients.

The new indication is based on results from the phase II CEPHEUS study, which compared the efficacy and safety of D-VRd and VRd. A total of 60.9% of patients achieved measurable residual disease (MRD)-negativity with D-VRd, compared to 39.4% of patients with VRd (odds ratio [OR], 2.37; 95% CI, 1.58-3.55; P<0.0001). D-VRd also reduced the risk of progression or death by 43% (hazard ratio, 0.57; 95% CI, 0.41-0.79; P<0.0005). The complete response rate was 81.2% for D-VRd and 61.6% for VRd (P<0.0001).

The safety profile of D-VRd was consistent with the known safety profiles for daratumumab and hyaluronidase-fihj and VRd.

“The subcutaneous daratumumab-based quadruplet regimen has compelling efficacy characterized by deep, durable responses and reduced risk of disease progression in the frontline population of patients not undergoing transplant, supporting the potential of this quadruplet to become a new regimen in this treatment setting,” Saad Z. Usmani, MD, FACP, Chief of Myeloma Service at the Memorial Sloan Kettering Cancer Center and study investigator, said in the press release.