FDA Approves Darzalex Faspro-VRd Combination for Newly Diagnosed Multiple Myeloma Patients Ineligible for Transplant

On January 27, 2026, the FDA approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).¹

Efficacy was demonstrated in the CEPHEUS trial (NCT03652064), which randomized 395 patients: 197 to the Darzalex Faspro-VRd arm and 198 to the VRd arm. The trial showed significant improvements in minimal residual disease negativity rates (52.3% vs 34.8%; P=.0005) and progression-free survival, with a hazard ratio of 0.60 (95% CI, 0.41-0.88; P=.0078).

Warnings and precautions include risks of hypersensitivity, infections, neutropenia, thrombocytopenia, embryo-fetal toxicity, and cardiac toxicity in patients with light chain (AL) amyloidosis. The recommended dose of Darzalex Faspro is 1800 mg/30,000 units administered subcutaneously.

Reference

1. FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-bortezomib-lenalidomide-and-dexamethasone-newly