Drug · Monoclonal Antibody
Tafasitamab
CI-DRUG-00000748Explore in graph →CHEMBL4298047 Approved
Regulatory
Approvals (6)
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
- Health Canada — Drug Product Database (DPD)
- Dataset
- Health Canada DPD
- Version
- dpd-2026-09-11
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- Open Government Licence – Canada (https://open.canada.ca/en/open-government-licence-canada)
- Run
- ING-HEALTHCANADADPD-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| CA Health Canada | — | Marketed in Canada as MINJUVI (DIN 02518627) under ATC L01FX12 TAFASITAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Dec 6, 2021 | health-canada-dpd |
| EU EMA | Diffuse Large B-Cell Lymphoma | Minjuvi is indicated in combination with lenalidomide followed by Minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).conditional | approved | Aug 26, 2021 | ema |
| US FDA | — | Efficacy supplement 2025-06-18 (see label) | approved | Jun 18, 2025 | 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 3 | 31 | 13 | 5 | 47 | 6 | CA, EU, US | Jul 31, 2020 | 2010-09 |
| Non-Hodgkin Lymphoma | Approved | Phase 3 | 24 | 8 | 5 | 34 | 4 | EU, US | Jul 31, 2020 | 2010-09 |
| Leukemia | Phase2 | Phase 2 | 6 | 3 | 0 | 11 | 0 | — | — | 2010-09 |
| Hodgkin Lymphoma | Phase2 | Phase 2 | 1 | 1 | 0 | 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 (50)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT06029309 | Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma(ZANU-TAFA) | recruiting | Phase 1 / Phase 2 | 27 | Alvaro Alencar, MDOTHER | 1 | Sep 21, 2026 | clinicaltrials |
| NCT05615636 | A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL | recruiting |