Drug · Monoclonal Antibody
Tarlatamab
CI-DRUG-00000764Explore in graph →CHEMBL5095292 Approved
Regulatory
Approvals (5)
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 IMDELLTRA (DIN 02551551) under ATC L01FX33 TARLATAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Nov 28, 2024 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as IMDELLTRA (DIN 02551578) under ATC L01FX33 TARLATAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Nov 28, 2024 | health-canada-dpd |
| EU EMA | Lung Small Cell Carcinoma | Imdylltra is indicated as monotherapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy. | approved | May 29, 2026 | ema |
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 18 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 | 30 | 18 | 7 | 34 | 5 | CA, EU, US | May 16, 2024 | Dec 26, 2017 |
| Malignant Lung Neoplasm | Approved | Phase 3 | 20 | 9 | 6 | 22 | 2 | EU, US | May 16, 2024 | Dec 26, 2017 |
| Malignant Bladder Neoplasm | Phase2 | Phase 2 | 1 | 1 | 0 | 1 | 0 | — | — | Sep 8, 2025 |
| Malignant Central Nervous System Neoplasm | Phase2 | Phase 2 | 1 | 1 | 0 | 1 |
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 (35)
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 |
|---|---|---|---|---|---|---|---|---|
| NCT07037758 | A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)(DeLLphi-311) | recruiting | Phase 1 | 380 | AmgenINDUSTRY | 3 | Sep 25, 2026 | clinicaltrials |
| NCT06814496 | Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors(RABBIT) |