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
- 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 2025-06-18 (see label) | approved | Jun 18, 2025 | openfda |
| US FDA | Diffuse Large B-Cell Lymphoma | in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).accelerated | approved | Jul 31, 2020 | openfda |
| US FDA | Follicular Lymphoma | in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). | approved | Jul 31, 2020 | openfda |
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 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 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 |