Drug · Monoclonal Antibody
Dostarlimab
CI-DRUG-00000193Explore in graph →NCIt C126799 CHEMBL4298124 CIViC Approved
Regulatory
Approvals (8)
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 JEMPERLI (DIN 02523434) under ATC L01FF07 DOSTARLIMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Feb 22, 2022 | health-canada-dpd |
| EU EMA | Malignant Endometrial Neoplasm | Jemperli is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy. Jemperli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability‑high (MSI‑H) recurrent or advanced EC that has progressed on or following prior treatment with a platinum‑containing regimen. | approved | Apr 21, 2021 | ema |
| US FDA | — | Efficacy supplement 2024-08-01 (see label) | approved | Aug 1, 2024 | 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 2 days 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 | 58 | 21 | 12 | 87 | 8 | CA, EU, US | Apr 21, 2021 | Mar 7, 2016 |
| Malignant Uterine Corpus Neoplasm | Approved | Phase 3 | 8 | 3 | 1 | 9 | 2 | EU, US | Apr 21, 2021 | Nov 6, 2017 |
| Malignant Lung Neoplasm | Phase3 | Phase 3 | 5 | 0 | 2 | 9 | 0 | — | — | Oct 12, 2017 |
| Malignant Ovarian Neoplasm | Phase3 | Phase 3 | 1 | 0 | 2 | 5 |
Curated evidence
Clinical evidence (3)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 36972026
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| High3 | ||||||||
| Carboplatin + Dostarlimab | ||||||||
Clinical trials
Trials with this intervention (89)
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 |
|---|---|---|---|---|---|---|---|---|
| NCT04584255 | Niraparib + Dostarlimab In BRCA Mutated Breast Cancer | active not recruiting | Phase 2 | 66 | Dana-Farber Cancer InstituteOTHER | 1 | Sep 24, 2026 | clinicaltrials |
| NCT06062420 | A Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck- GALAXIES H&N-202 | active not recruiting |