Drug · Monoclonal Antibody
Daratumumab
CI-DRUG-00000726Explore in graph →CHEMBL1743007 Approved
Regulatory
Approvals (19)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2025-04-10 (see label) | approved | Apr 10, 2025 | openfda |
| US FDA | — | Efficacy supplement 2025-01-23 (see label) | approved | Jan 23, 2025 | openfda |
| US FDA | — | Efficacy supplement 2024-07-31 (see label) | approved | Jul 31, 2024 | openfda |
| US FDA | — | Efficacy supplement 2023-01-19 (see label) | approved | Jan 19, 2023 | openfda |
| US |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 14 days agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 139 | 61 | 57 | 254 | 19 | CA, EU, US | Nov 16, 2015 | Jan 31, 2012 |
| Non-Hodgkin Lymphoma | Approved | Phase 4 | 121 | 50 | 54 | 218 | 1 | US | Nov 16, 2015 | Jan 31, 2012 |
| Multiple Myeloma | Approved | Phase 4 | 112 | 44 | 53 | 198 | 1 | US | Nov 16, 2015 | Jan 31, 2012 |
| Leukemia | Phase3 | Phase 3 | 8 | 6 | 2 | 18 | 0 | — |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
Clinical trials
Trials with this intervention (261)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT04181827 | A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma(CARTITUDE-4) | active not recruiting | Phase 3 | 419 | Janssen Research & Development, LLCINDUSTRY | 16 | Sep 28, 2026 | clinicaltrials |
| NCT04722146 |