FDA ApprovesJ&J Daratumumab and Hyaluronidase Plus VRd for Newly Diagnosed Multiple Myeloma

 The FDA has approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).1

This regulatory decision was supported by data from the phase 3 CEPHEUS trial (NCT03652064), in which daratumumab and hyaluronidase plus VRd (n = 197) elicited a minimal residual disease (MRD) negativity rate of 52.3% vs 34.8% with VRd alone (n = 198; P = .0005).1,2 The daratumumab-based combination also generated an improvement in progression-free survival (PFS), although the median pPFS was not reached (95% CI, not evaluable [NE]-NE) in both arms (HR, 0.60; 95% CI, 0.41-0.88; P = .0078).

https://www.onclive.com/view/fda-approves-daratumumab-and-hyaluronidase-plus-vrd-for-newly-diagnosed-multiple-myeloma