On January 27, 2026, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Daratumumab and Hyaluronidase-fihj Injection (Darzalex Faspro) in combination with bortezomib, lenalidomide, and dexamethasone (the D-VRd regimen) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (ASCT). The D-VRd regimen is currently the only anti-CD38 antibody-based regimen approved for use across all newly diagnosed patients, regardless of transplant eligibility.

About the CEPHEUS Study

The CEPHEUS study ([ClinicalTrials.gov](ClinicalTrials.gov) Identifier: NCT03652064) is a multicenter, randomized, open-label Phase 3 clinical trial designed to compare the efficacy and safety of the D-VRd regimen versus the VRd regimen in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation or who decline ASCT during the initial treatment phase. The primary endpoint of the study was the overall minimal residual disease (MRD)-negative rate at a sensitivity level of 10⁻⁵. Secondary endpoints included complete response or better rate, progression-free survival (PFS), sustained MRD-negative rate, 1-year MRD-negative rate, overall response rate, time to response and duration of response, progression-free survival on subsequent lines of therapy, overall survival, and safety. The study enrolled a total of 395 patients across 13 countries in North America, South America, and Europe.

About Multiple Myeloma

Multiple myeloma is a hematologic malignancy that primarily affects plasma cells, a type of white blood cell found in the bone marrow. In patients with multiple myeloma, malignant plasma cells proliferate abnormally and displace healthy cells within the bone marrow. As the second most common hematologic malignancy worldwide, multiple myeloma remains an incurable disease at present. It is estimated that in 2026, more than 36,000 people in the United States will be diagnosed with multiple myeloma, and over 12,000 will die from the disease. The 5-year survival rate for patients with multiple myeloma is 59.8%. Some patients are asymptomatic at diagnosis, but most are diagnosed due to related symptoms, which commonly include bone fractures or bone pain, reduced red blood cell count, fatigue, hypercalcemia, renal dysfunction, or infections.

About Daratumumab and Hyaluronidase-fihj Injection and Daratumumab

Daratumumab and Hyaluronidase-fihj Injection received approval from the U.S. FDA in May 2020 and currently holds a total of 11 approved indications in the field of multiple myeloma, including 5 for first-line treatment of newly diagnosed patients who are eligible or ineligible for transplantation¹. It is the only subcutaneously administered anti-CD38 monoclonal antibody approved for the treatment of multiple myeloma. Daratumumab and Hyaluronidase-fihj Injection is a fixed-dose combination formulation utilizing recombinant human hyaluronidase PH20 (rHuPH20), leveraging Halozyme Therapeutics, Inc.’s ENHANZE drug delivery technology.

Daratumumab (Darzalex) was approved by the U.S. FDA in November 2015 and currently has 8 approved indications in total, including 3 first-line indications covering newly diagnosed patients who are both eligible and ineligible for transplantation. Daratumumab was the first anti-CD38 monoclonal antibody approved for the treatment of multiple myeloma.

Worldwide, more than 720,000 patients have been treated with daratumumab-based regimens.

In August 2012, Janssen Biotech, Inc. entered into a global collaboration agreement with Genmab A/S, granting Janssen exclusive rights to the research, development, manufacturing, and commercialization of daratumumab.