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% with D-VRd versus 34.8% 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%). 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%).
“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.
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