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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
D-VRd regimen nearly doubles sustained minimal residual disease-negativity and reduces progression or death risk by 40%, supporting its use for transplant-ineligible myeloma patients.
- Johnson & Johnson said the FDA approved DARZALEX FASPRO with D‑VRd for transplant‑ineligible NDMM adults.
- The CEPHEUS Phase 3 trial used MRD‑negativity at 10‑5 as its primary endpoint, comparing D‑VRd to VRd in ASCT‑ineligible or deferred NDMM patients and showing increased response depth and reduced progression risk.
- CEPHEUS findings reported MRD‑negativity 52.3 vs 34.8 at 22 months and sustained MRD‑negativity 42.6 vs 25.3, with a hazard ratio 0.60, indicating a 40% risk reduction.
- The decision expands DARZALEX FASPRO's label by marking its twelfth indication and fifth in the newly diagnosed setting, making D‑VRd the only anti‑CD38 antibody‑based regimen approved across newly diagnosed patients.
- Safety data show in a pooled safety population serious infections occurred in 24%, Grade 3/4 infections 22%, fatal infections 2.5%, with infusion‑related reactions at 37% Week 1.
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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
Darzalex Faspro Quadruplet OK’d for Transplant-Ineligible MM
The subcutaneous injection can now be used with bortezomib, lenalidomide, and dexamethasone for newly diagnosed patients regardless of transplant eligibility. Medscape Medical News Source link : https://www.medscape.com/viewarticle/darzalex-faspro-quadruplet-okd-transplant-ineligible-2026a10002sh?src=rss Author : Publish date : 2026-01-29 04:57:00 Copyright for syndicated content belongs to the linked Source. The post Darzalex Faspro Quadruplet …
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Leaning Left2Leaning Right2Center3Last UpdatedBias Distribution43% Center
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43% Center
L 29%
C 43%
R 28%
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