DARZALEX FASPRO®-based quadruplet regimen approved in the U.S. for newly diagnosed patients with multiple myeloma who are transplant ineligible

Core Insights - The FDA has approved DARZALEX FASPRO in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant, marking the twelfth indication for DARZALEX FASPRO and the fifth in the newly diagnosed setting [1][3][8] Group 1: Approval and Efficacy - D-VRd demonstrated significantly deeper and more durable responses, higher minimal residual disease (MRD) negativity, and improved progression-free survival compared to the standard VRd regimen [1][3] - The pivotal Phase 3 CEPHEUS study showed that D-VRd increased the overall MRD-negativity rate to 52.3% versus 34.8% with VRd at a sensitivity threshold of 10 [2][4] - At a median follow-up of 39 months, the sustained MRD-negativity rate of 12 months was 42.6% for D-VRd compared to 25.3% for VRd [4] Group 2: Safety and Adverse Events - The overall safety profile of DARZALEX FASPRO combined with VRd was consistent with known adverse reactions for both components, with common adverse events including upper respiratory tract infection, sensory neuropathy, and musculoskeletal pain [5][28] - Serious infections occurred in 24% of patients, with pneumonia being the most common serious infection reported at 8.5% [21][28] - Injection-site reactions were reported in 8% of patients, with the most frequent being erythema and rash [20][28] Group 3: Study Details and Patient Population - The CEPHEUS study was a multicenter, randomized, open-label Phase 3 trial that enrolled 395 patients across 13 countries, focusing on those newly diagnosed with multiple myeloma who were ineligible for ASCT [6] - The primary endpoint was the overall MRD-negativity rate, with secondary endpoints including complete response rates and progression-free survival [6] Group 4: Background on Multiple Myeloma - Multiple myeloma is the second most common blood cancer globally, with an estimated 36,000 new diagnoses in the U.S. in 2026 and a 5-year survival rate of 59.8% [7]