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DARZALEX FASPRO®-based quadruplet regimen approved in the U.S. for newly diagnosed patients with multiple myeloma who are transplant ineligible
FDA approval of DARZALEX FASPRO quadruplet for transplant-ineligible myeloma patients is based on CEPHEUS Phase 3 trial showing 40% risk reduction in progression or death.
- Yesterday, the U.S. Food and Drug Administration approved DARZALEX FASPRO with bortezomib, lenalidomide and dexamethasone for adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
- The pivotal Phase 3 CEPHEUS trial reported D‑VRd increased MRD‑negativity and nearly doubled sustained MRD‑negativity compared to VRd, reducing progression or death risk by 40%.
- The pivotal trial enrolled 395 patients in 13 countries as the Phase 3 study supporting the filing, and DARZALEX FASPRO is a subcutaneous co‑formulation with Halozyme's ENHANZE drug‑delivery technology .
- Saad Z. Usmani said D‑VRd increased response depth and durability, significantly reduced progression risk, and nearly doubled sustained minimal residual disease rates, making it the only anti‑CD38 antibody‑based regimen approved for all newly diagnosed patients.
- Clinicians should note DARZALEX FASPRO safety profile includes serious infections in 24% of the pooled safety population and indirect antiglobulin test interference requires notifying blood transfusion centers and blood banks.
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DARZALEX FASPRO®-based quadruplet regimen approved in the U.S. for newly diagnosed patients with multiple myeloma who are transplant ineligible
Quadruplet regimen demonstrated significantly deeper and more durable responses, higher MRD negativity and improved progression-free survival versus a standard of care
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R 28%
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