Quadruplet regimen demonstrated significantly deeper and more durable responses, higher MRD negativity and improved progression-free survival versus a standard of care
Approval marks the twelfth indication for DARZALEX FASPRO® and fifth in the newly diagnosed setting, underscoring its role as foundational therapy for both newly diagnosed and relapsed/refractory multiple myeloma patients
HORSHAM, Pa., Jan. 27, 2026 /PRNewswire/ — Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (FDA) 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 (NDMM) 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 transplant eligibility.
The pivotal Phase 3 CEPHEUS study (NCT03652064) evaluated the efficacy and safety of D-VRd compared to bortezomib, lenalidomide and dexamethasone (VRd) in NDMM patients who were ineligible for ASCT or deferred ASCT as initial therapy.1 Today’s milestone follows approval for D-VRd for the treatment of patients who are newly diagnosed with multiple myeloma and eligible for ASCT.2
“D-VRd increased the depth and durability of responses, significantly reduced the risk of disease progression or death, and nearly doubled the rate of sustained minimal residual disease (MRD)-negativity compared to VRd in patients ineligible for ASCT, solidifying this regimen as a potential standard of care for newly diagnosed patients with multiple myeloma,” said Saad Z. Usmani, M.D., Chief, Myeloma Service, Memorial Sloan Kettering Cancer Center and CEPHEUS principal investigator.* “MRD-negativity is a potential predictor of prolonged progression-free and overall survival and D-VRd is now the only quadruplet regimen approved by the FDA based on a study with MRD-negativity as a primary endpoint.”
“This approval marks the twelfth 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,” said June Lanoue, U.S. President, Hematology, Johnson & Johnson Innovative Medicine. “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.”
Findings from CEPHEUS showed that at a median follow-up of 22 months, the overall MRD-negativity rate at a sensitivity of 10-5 (no cancer cells detected within 100,000 bone marrow cells) was 52.3 percent vs 34.8 percent with VRd (P