Drug · Monoclonal Antibody
Glofitamab
CI-DRUG-00000756Explore in graph →CHEMBL4298092 Approved
Regulatory
Approvals (4)
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 COLUMVI (DIN 02536552) under ATC L01FX28 GLOFITAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 5, 2023 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as COLUMVI (DIN 02536560) under ATC L01FX28 GLOFITAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 5, 2023 | health-canada-dpd |
| EU EMA | Diffuse Large B-Cell Lymphoma | Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT).Columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), after two or more lines of systemic therapy. | approved |
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 19 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 | 58 | 25 | 4 | 69 | 4 | CA, EU, US | Jun 15, 2023 | Feb 21, 2017 |
| Non-Hodgkin Lymphoma | Approved | Phase 3 | 32 | 14 | 2 | 40 | 1 | EU | Jul 7, 2023 | Feb 21, 2017 |
| Leukemia | Phase2 | Phase 2 | 1 | 1 | 0 | 1 | 0 | — | — | Jan 22, 2024 |
| Malignant Central Nervous System Neoplasm | Phase1 | Phase 1 | 0 | 0 | 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 (75)
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 |
|---|---|---|---|---|---|---|---|---|
| NCT06252675 | Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma | recruiting | Phase 2 | 30 | University of California, San FranciscoOTHER | 1 | Sep 28, 2026 | clinicaltrials |
| NCT05783596 | Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma | active not recruiting | Phase 2 |