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

Full prescribing information for Darzalex Faspro will be posted on Drugs@FDA .

Efficacy and Safety

Efficacy was 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 effectiveness of DARZALEX FASPRO-VRd has not been established in patients who refused ASCT as initial therapy.

A total of 395 patients were randomized: 197 to the Darzalex Faspro-VRd arm and 198 to the VRd arm. The major efficacy outcome measures were overall minimal residual disease (MRD) negativity rate and progression-free survival (PFS) by independent review committee (IRC) based on International Myeloma Working Group (IMWG) response criteria. The MRD negativity rate was 52.3% in the Darzalex Faspro-VRd arm and 34.8% in the VRd arm (p-value 0.0005). The PFS hazard ratio was 0.60 [95% CI: 0.41, 0.88]; p-value 0.0078].

The prescribing information includes Warnings and Precautions for hypersensitivity and other administration reactions, , infections, neutropenia, thrombocytopenia, embryo-fetal toxicity interference with cross-matching and red blood cell antibody screening, and cardiac toxicity in patients with light chain (AL) amyloidosis.

Recommended Dosage

The recommended Darzalex Faspro dose is 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase). See the prescribing information for the dosage recommendations for the other drugs.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. 

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