On Tuesday, January 27, the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro (daratumumab and hyaluronidase-fihj)  in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of “adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).”

Efficacy was based on the results of the CEPHEUS study — an open-label, randomized clinical trial in people with newly diagnosed multiple myeloma who were not eligible for autologous stem cell transplant (ASCT) or chose not to receive ASCT as their first treatment.  

However, the benefit of Darzalex Faspro-VRd has not been established specifically in patients who refused ASCT as initial therapy.

A total of 395 patients were enrolled, with 197 patients receiving Darzalex Faspro plus VRd and 198 patients receiving VRd alone.

Main results 
The major efficacy outcomes measured were:

• Overall minimal residual disease (MRD) negativity rate, and 
• Progression-free survival (PFS), assessed by an independent review committee (IRC) using the International Myeloma Working Group (IMWG) criteria.

Results showed:

• MRD negativity in 52.3% of patients treated with Darzalex Faspro-VRd, compared with 34.8% with VRd alone (p = 0.0005) 
• The PFS hazard ratio was 0.60 [95% CI: 0.41, 0.88]; p-value 0.0078].

Safety information 
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 
• Cardiac toxicity in patients with light chain (AL) amyloidosis

Dosing 
The recommended dose of Darzalex Faspro is 1,800 mg/30,000 units (1,800 mg daratumumab with 30,000 units hyaluronidase). Dosing details for the other drugs in the regimen are provided in their prescribing information.

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

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

Reference: 
FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma, Resources for Information on Approved Drugs, U.S. Food and Drug Administration. January 27, 2026.