Approval is for adult patients ineligible for autologous stem cell transplant<\/p>\n<\/h3>\n
By Lori Solomon HealthDay Reporter<\/b>
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WEDNESDAY, Feb. 4, 2026 (HealthDay News) — The U.S. Food and Drug Administration has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant (ASCT).<\/p>\n
D-VRd is the only anti-CD38 antibody-based regimen with approved indications across newly diagnosed patients, regardless of ASCT eligibility.<\/p>\n
The approval is based on the phase 3 CEPHEUS trial, which enrolled 395 patients. Results showed that at a median follow-up of 22 months, the overall minimal residual disease (MRD)-negativity rate at a sensitivity of 10-5<\/sup> (no cancer cells detected within 100,000 bone marrow cells) was 52.3 percent with D-VRd versus 34.8 percent with VRd alone. The proportion of patients achieving sustained MRD-negativity of \u226512 months almost doubled at a median follow-up of 39 months (42.6 versus 25.3 percent). D-VRd also significantly reduced the risk for progression or death (hazard ratio, 0.60) compared with VRd. At a median follow-up of 59 months, D-VRd significantly increased the depth of response, with higher rates of complete response or better observed versus VRd (81.2 versus 61.6 percent). <\/p>\n “This approval marks the 12th indication for Darzalex Faspro overall and fifth in newly diagnosed multiple myeloma, underscoring its role as foundational therapy for both newly diagnosed and relapsed\/refractory patients,” June Lanoue, from Johnson & Johnson Innovative Medicine, said in a statement. “CEPHEUS demonstrated the efficacy of a Darzalex Faspro-based quadruplet as a frontline standard of care. With this approval, patients can receive D-VRd when they are first diagnosed with multiple myeloma, an important milestone as we work to one day deliver a functional cure.”<\/p>\n Approval of Darzalex Faspro was granted to Johnson & Johnson. <\/p>\n