HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) said the U.S. Food and Drug Administration has approved a new frontline treatment option for adults newly diagnosed with multiple myeloma who are not eligible for stem cell transplant, marking a significant expansion in care for one of the most common blood cancers.
The approval clears DARZALEX FASPRO, a subcutaneous formulation of daratumumab combined with bortezomib, lenalidomide and dexamethasone, known as D-VRd, for patients ineligible for autologous stem cell transplant. Johnson & Johnson said the decision makes D-VRd the only anti-CD38 antibody-based regimen approved across newly diagnosed multiple myeloma patients regardless of transplant eligibility.
The FDA decision was based on results from the Phase 3 CEPHEUS trial, which compared D-VRd with the standard VRd regimen in patients who were either ineligible for or deferred stem cell transplant as initial therapy. The study enrolled 395 patients across 13 countries and focused on minimal residual disease, or MRD, negativity as its primary endpoint.
At a median follow-up of 22 months, more than half of patients receiving D-VRd achieved MRD-negativity at a sensitivity of 10⁻⁵, compared with just under 35 percent for those receiving VRd alone. Longer-term follow-up showed that sustained MRD-negativity lasting at least 12 months nearly doubled in the D-VRd group, while the risk of disease progression or death was reduced by 40 percent compared with standard therapy.
Dr. Saad Z. Usmani, chief of the Myeloma Service at Memorial Sloan Kettering Cancer Center and principal investigator of the CEPHEUS study, said the results demonstrated deeper and more durable responses, positioning the regimen as a potential new standard of care for patients unable to undergo transplant.
Johnson & Johnson said the approval represents the twelfth overall indication for DARZALEX FASPRO and the fifth in newly diagnosed multiple myeloma, reinforcing the drug’s role as a foundational therapy in both frontline and relapsed settings. Company executives said the decision allows patients to receive the quadruplet regimen immediately after diagnosis, a step they described as critical in the long-term effort to improve survival outcomes.
Safety findings in the study were consistent with the known profiles of DARZALEX FASPRO and the VRd regimen. The most commonly reported side effects included infections, neuropathy, fatigue, gastrointestinal symptoms, musculoskeletal pain, and respiratory complications. Overall survival data from the trial have not yet matured.
Multiple myeloma is the second most common blood cancer worldwide and remains incurable. An estimated 36,000 people in the United States are expected to be diagnosed with the disease in 2026, with more than 12,000 deaths projected. Despite advances in treatment, the five-year survival rate remains just under 60 percent.
DARZALEX FASPRO is the only subcutaneous CD38-directed antibody approved for multiple myeloma and is co-formulated with Halozyme’s ENHANZE drug delivery technology. Johnson & Johnson said daratumumab-based regimens have now been used to treat more than 720,000 patients globally, reflecting their expanding role in modern myeloma care.
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