Daratumumab is an anti-CD38 human monoclonal antibody therapy used in multiple myeloma treatment, including combination regimens in newly diagnosed and relapsed settings. It is marketed as Darzalex and Darzalex SC. The drug is prescription-only in major markets.
FDA approval of daratumumab for high-risk smoldering multiple myeloma marks a shift from observation to early intervention. In a Phase II trial in earlier-stage disease, the overall response rate was 54% and the primary endpoint was not met.
Phase 3 trial data show daratumumab reduced relapse risk by 74% in NMOSD. Separately, the FDA accepted an NDA for iberdomide plus daratumumab/dexamethasone in relapsed/refractory multiple myeloma, with a PDUFA date of August 17, 2026.
The multiple myeloma treatment landscape is rapidly expanding with over 75 companies developing 80+ pipeline therapies, while clinicians navigate evolving questions about transplant timing, quadruplet regimens, and minimal residual disease testing in newly diagnosed patients.
Global orphan drug sales are forecast to reach $409 billion by 2032, representing one-fifth of prescription drug sales, with Johnson & Johnson and Argenx leading the market amid regulatory uncertainty.
MajesTEC-9 trial demonstrates teclistamab's superiority over standard care in second-line multiple myeloma treatment, with significant progression-free survival and overall survival benefits supporting earlier use of the BCMA-targeting bispecific antibody.
The FDA has granted fast track designation to QRX003 for Netherton Syndrome and IBI3003 for relapsed or refractory multiple myeloma, while also accepting regulatory applications for other therapies addressing serious conditions with unmet medical needs.
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.
Novel CELMoD agents are being evaluated to address T-cell exhaustion in multiple myeloma patients, while CAR T-cell therapy CARVYKTI shows longer-term survival benefits. Nearly 200,000 people in the U.S. live with this blood cancer.
The FDA has accepted for Priority Review Bristol Myers Squibb's New Drug Application for iberdomide in combination with daratumumab and dexamethasone for relapsed or refractory multiple myeloma, with a target decision date of August 17, 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07555938 |
Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma |
NOT_YET_RECRUITING | PHASE3 |
| NCT07513129 |
Venetoclax, Dexamethasone, Bortezomib, and Daratumumab For The Treatment Of Adolescent And Young Adults With Relapsed Or Refractory T-Cell Acute Lymphoblastic Leukemia And T-cell Acute Lymphoblastic Lymphoma |
NOT_YET_RECRUITING | PHASE1 |
| NCT07452198 |
A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma |
RECRUITING | PHASE3 |
| NCT07428369 |
A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07393282 |
A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM) |
NOT_YET_RECRUITING | PHASE3 |
| NCT07391657 |
A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4) |
RECRUITING | PHASE3 |
| NCT07362238 |
Daratumumab Versus Rituximab in the Management of Pediatric Primary Immune Thrombocytopenia (ITP) |
RECRUITING | PHASE2 |
| NCT07341867 |
Systemic Anti-Cancer Therapy Dose Modifications for Individuals With Duffy Null Phenotype |
NOT_YET_RECRUITING | PHASE1 |
| NCT07335887 |
Sonrotoclax Plus Dexamethasone With or Without Daratumumab Regimen in Patients With t(11;14) Primary AL Amyloidosis |
NOT_YET_RECRUITING | PHASE2 |
| NCT07297563 |
Anti-CD38 Monoclonal Antibody Versus Rituximab in the Management of Primary Immune Thrombocytopenia (ITP) |
RECRUITING | PHASE2 |
