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.

emaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
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

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.

civicCuratedShowing 1–3 of 3 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

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.

clinicaltrialsPublishedShowing 1–50 of 89 studies · status and phase as posted by the registrant; each row links to the study record.

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

Molecule

Record

Kind: Monoclonal Antibody
Mechanism: Programmed cell death protein 1 antagonist
Targets: 1 gene
UNII: P0GVQ9A4S5
Aliases: ANB011, Dostarlimab, Dostarlimab-gxly, GSK-4057190, GSK4057190, Immunoglobulin G4, Anti-programmed Cell Death Protein 1 (PDCD1) (Humanized Clone ABT1 Gamma4-chain), Disulfide With Humanized Clone ABT1 Kappa-chain, Dimer, Jemperli, JEMPERLI, TSR 042, TSR-042, TSR042, WBP-285, WBP285

Data updated 21 minutes agoSource updated unknown

Identifiers

Codes (4)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01FF07	DOSTARLIMAB
DIN (Health Canada)	02523434	JEMPERLI