DARZALEX FASPRO is the fixed-dose subcutaneous combination of daratumumab and hyaluronidase for adult multiple myeloma treatment across newly diagnosed and relapsed/refractory settings, with additional high-risk smoldering myeloma and amyloidosis indications in the U.S. It combines a CD38-directed cytolytic antibody with an endoglycosidase component. The product is prescription-only.
The FDA approved Tecvayli plus Darzalex Faspro for relapsed or refractory multiple myeloma after at least one prior therapy, and accepted a new drug application for iberdomide plus daratumumab and dexamethasone with a PDUFA date of August 17, 2026.
The FDA approved Tecvayli plus Darzalex Faspro for relapsed/refractory multiple myeloma in March 2026, and Darzalex Faspro-based quadruplet D-VRd for newly diagnosed transplant-ineligible patients in January 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06742138 |
To Evaluate the Efficacy and Safety of QL2109 and DARZALEX FASPRO® in Multiple Myeloma |
NOT_YET_RECRUITING | PHASE3 |
| NCT06371534 |
A Study Comparing Pharmacokinetic and Safety of QL2109 and DARZALEX FASPRO® in Healthy Adults |
RECRUITING | PHASE1 |
