Drug · Monoclonal Antibody
Teclistamab
CI-DRUG-00000757Explore in graph →CHEMBL4594505 Approved
Regulatory
Approvals (7)
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-2026-09-29
- Retrieved
- Sep 29, 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-20260929-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| CA Health Canada | — | Marketed in Canada as TECVAYLI (DIN 02539764) under ATC L01FX24 TECLISTAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Oct 20, 2023 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as TECVAYLI (DIN 02539756) under ATC L01FX24 TECLISTAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Oct 20, 2023 | health-canada-dpd |
| EU EMA | Multiple Myeloma | Tecvayli is indicated in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. |
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 4 | 50 | 28 | 11 | 53 | 7 | CA, EU, US | Aug 23, 2022 | May 16, 2017 |
| Non-Hodgkin Lymphoma | Approved | Phase 4 | 44 | 26 | 11 | 46 | 2 | EU, US | Aug 23, 2022 | Aug 9, 2019 |
| Multiple Myeloma | Approved | Phase 4 | 38 | 22 | 11 | 40 | 2 | EU, US | Aug 23, 2022 | Aug 9, 2019 |
| Leukemia | Phase3 | Phase 3 | 3 | 3 | 1 | 3 | 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 (57)
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 |
|---|---|---|---|---|---|---|---|---|
| NCT04722146 | A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma(MajesTEC-2) | active not recruiting | Phase 1 | 140 | Janssen Research & Development, LLCINDUSTRY | 5 | Sep 28, 2026 | clinicaltrials |
| NCT06425991 | A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma |