Skip to main content
See every side of every news story
Published loading...Updated

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.
Insights by Ground AI

25 Articles

Bennington BannerBennington Banner
+19 Reposted by 19 other sources
Center

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

Think freely.Subscribe and get full access to Ground NewsSubscriptions start at $9.99/yearSubscribe

Bias Distribution

  • 43% of the sources are Center
43% Center

Factuality Info Icon

To view factuality data please Upgrade to Premium

Ownership

Info Icon

To view ownership data please Upgrade to Vantage

cancernetwork.com broke the news in on Tuesday, January 27, 2026.
Too Big Arrow Icon
Sources are mostly out of (0)

Similar News Topics

News
Feed Dots Icon
For You
Search Icon
Search
Blindspot LogoBlindspotLocal