FDA Clears Daratumumab-Hyaluronidase Quadruplet with VRd for Transplant-Ineligible Multiple Myeloma

The U.S. Food and Drug Administration has approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for the treatment of adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The decision expands frontline options for a patient population with limited intensive therapy alternatives.

Expanded Frontline Therapeutic Option

The approval is supported by data from the Phase III CEPHEUS study showing that D-VRd delivers deeper, more durable responses than standard VRd alone, including higher minimal residual disease-negativity rates and longer progression-free survival. This marks a meaningful advance in first-line care, particularly for patients unable to undergo transplant.

Strategic Implications for Multiple Myeloma Care

This indication makes D-VRd the only anti-CD38 antibody-based regimen approved across newly diagnosed multiple myeloma patients regardless of transplant eligibility, further solidifying Darzalex Faspro’s role as foundational therapy in both frontline and later lines of treatment. Clinicians may now consider quadruplet therapy earlier in the disease course for appropriate patients.