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
- 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 2026-03-05 (see label) | approved | Mar 5, 2026 | openfda |
| US FDA | — | Efficacy supplement 2024-11-22 (see label) | approved | Nov 22, 2024 | openfda |
| US FDA | — | Efficacy supplement 2024-02-20 (see label) | approved | Feb 20, 2024 | openfda |
| US FDA | Multiple Myeloma | TECVAYLI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. TECVAYLI is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma: in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent ( 1 ). as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody ( 1 ). |
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 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 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT05463939 | Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients | approved for marketing | — | — | Janssen Research & Development, LLCINDUSTRY | 0 | Jun 15, 2025 | clinicaltrials |
| NCT06935162 | Teclistamab in Previously Treated AL Amyloidosis | recruiting | Phase 2 |