Silver Spring, Md. – February 4, 2026 – The U.S. Food and Drug Administration (FDA) has approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (the D-VRd regimen) for the treatment of adult patients with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant (ASCT).

About the D-VRd Regimen

The D-VRd regimen is the only anti-CD38 monoclonal antibody-based therapy approved for use across all newly diagnosed patients, regardless of ASCT eligibility.

Phase 3 CEPHEUS Clinical Trial

The approval is supported by data from the Phase 3 CEPHEUS clinical trial, which enrolled a total of 395 patients.

At a median follow-up of 22 months, the minimal residual disease (MRD)-negative rate at the 10⁻⁵ sensitivity threshold (defined as no cancer cells detected per 100,000 bone marrow cells) was 52.3% in the D-VRd arm, compared with 34.8% in the VRd monotherapy arm.

At a median follow-up of 39 months, the proportion of patients achieving sustained MRD negativity for ≥12 months nearly doubled in the D-VRd arm, reaching 42.6%, versus 25.3% in the control arm.

Compared with the VRd regimen, D-VRd significantly reduced the risk of disease progression or death (hazard ratio = 0.60).

At a median follow-up of 59 months, the D-VRd arm achieved a substantially deeper response, with a complete response or better (CR+) rate of 81.2%, markedly higher than the 61.6% rate observed in the VRd arm.

Related Statement

June Lanoue of Janssen Innovative Pharmaceuticals commented:

“This approval marks the 12th indication for daratumumab and hyaluronidase-fihj, and its 5th indication in newly diagnosed multiple myeloma, firmly solidifying the medicine’s role as a backbone therapy for patients with newly diagnosed and relapsed/refractory multiple myeloma. The CEPHEUS study validates that the four-drug combination regimen centered on daratumumab and hyaluronidase-fihj can be adopted as a standard-of-care frontline treatment.”

“With this approval, patients with multiple myeloma can now receive D-VRd as initial therapy, representing a pivotal milestone in our pursuit of the ultimate goal: achieving functional cure for this disease.”