Drug · Monoclonal Antibody
Blinatumomab
CI-DRUG-00000724Explore in graph →CHEMBL1742992 Approved
Regulatory
Approvals (13)
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 2024-06-14 (see label) | approved | Jun 14, 2024 | openfda |
| US FDA | — | Efficacy supplement 2023-06-20 (see label) | approved | Jun 20, 2023 | openfda |
| US FDA | — | Efficacy supplement 2023-06-20 (see label) | approved | Jun 20, 2023 | openfda |
| US FDA | — | Efficacy supplement 2021-03-11 (see label) | approved | Mar 11, 2021 | 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 15 hours 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 | 83 | 41 | 24 | 137 | 13 | CA, EU, US | Dec 3, 2014 | 2004-06 |
| Leukemia | Approved | Phase 3 | 69 | 37 | 19 | 104 | 4 | EU, US | Dec 3, 2014 | 2008-01 |
| Non-Hodgkin Lymphoma | Phase3 | Phase 3 | 8 | 4 | 3 | 18 | 0 | — | — | 2004-06 |
| Malignant Central Nervous System Neoplasm | Phase3 | Phase 3 | 1 | 1 | 1 | 1 | 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 (141)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT03263572 | Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia | recruiting | Phase 2 | 90 | M.D. Anderson Cancer CenterOTHER | 1 | May 20, 2026 | clinicaltrials |
| NCT07134088 | A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia |