FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma

Regulatory approval: On January 27, 2026, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). Approval was based on the open-label randomized CEPHEUS trial, which showed higher MRD negativity and improved PFS versus VRd alone. Effectiveness has not been established in patients who refused ASCT as initial therapy.

FDA approval: Darzalex Faspro + VRd in transplant-ineligible newly diagnosed multiple myeloma

Type: Regulatory approval (FDA)
Date: 2026-01-27

The FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro; Janssen Biotech, Inc.) with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant (ASCT).

Supporting evidence

Efficacy and safety were evaluated in CEPHEUS (NCT03652064), an open-label, randomized, active-controlled trial in patients with newly diagnosed multiple myeloma who were ineligible for ASCT or refused ASCT as initial therapy. The FDA noted that the effectiveness of Darzalex Faspro–VRd has not been established in patients who refused ASCT as initial therapy.

Patients: 395 randomized (Darzalex Faspro–VRd n=197; VRd n=198).
Primary efficacy outcomes: overall MRD negativity rate and PFS by independent review committee using IMWG criteria.

  • MRD negativity: 52.3% vs 34.8% (p=0.0005)
  • PFS: HR 0.60 (95% CI, 0.41–0.88); p=0.0078

Key labeling considerations

Warnings/precautions include hypersensitivity and other administration reactions, infections, neutropenia, thrombocytopenia, embryo-fetal toxicity, interference with cross-matching and RBC antibody screening, and cardiac toxicity in patients with light chain (AL) amyloidosis.

Recommended dose (Darzalex Faspro): 1,800 mg/30,000 units (daratumumab/hyaluronidase). Full prescribing information will be posted on Drugs@FDA.

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