FDA Approves Quadruplet Regimen for Adults With Newly Diagnosed Multiple Myeloma

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).D-VRd is the only anti-CD38 antibody-based regimen with approved indications across newly diagnosed patients, regardless of ASCT eligibility.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 (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 ≥12 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). "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."Approval of Darzalex Faspro was granted to Johnson & Johnson. More Information.Sign up for our weekly HealthDay newsletter

FDA Approves Quadruplet Regimen for Adults With Newly Diagnosed Multiple Myeloma

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