Drug Type Monoclonal antibody |
Synonyms Dostarlimab, Dostarlimab subcutaneous injection(Tesaro), Immunoglobulin G4, anti-programmed cell death protein 1 (PDCD1) (humanized clone ABT1 gamma4-chain), disulfide with humanized clone ABT1 kappa-chain, dimer + [12] |
Target |
Action inhibitors |
Mechanism PD-1 inhibitors(Programmed cell death protein 1 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (21 Apr 2021), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Priority Review (Australia), Commissioner's National Priority Voucher (United States) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11366 | Dostarlimab-gxly |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Advanced Endometrial Carcinoma | European Union | 12 Jan 2024 | |
| Advanced Endometrial Carcinoma | Iceland | 12 Jan 2024 | |
| Advanced Endometrial Carcinoma | Liechtenstein | 12 Jan 2024 | |
| Advanced Endometrial Carcinoma | Norway | 12 Jan 2024 | |
| Recurrent Endometrial Cancer | European Union | 12 Jan 2024 | |
| Recurrent Endometrial Cancer | Iceland | 12 Jan 2024 | |
| Recurrent Endometrial Cancer | Liechtenstein | 12 Jan 2024 | |
| Recurrent Endometrial Cancer | Norway | 12 Jan 2024 | |
| MSI-H/dMMR Solid Tumors | United States | 17 Aug 2021 | |
| Mismatch repair-deficient Endometrial Carcinoma | European Union | 21 Apr 2021 | |
| Mismatch repair-deficient Endometrial Carcinoma | Iceland | 21 Apr 2021 | |
| Mismatch repair-deficient Endometrial Carcinoma | Liechtenstein | 21 Apr 2021 | |
| Mismatch repair-deficient Endometrial Carcinoma | Norway | 21 Apr 2021 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| MSI-H/dMMR Rectal Cancer | Phase 3 | - | 17 Sep 2026 | |
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | United States | 10 Jun 2024 | |
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | China | 10 Jun 2024 | |
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | Japan | 10 Jun 2024 | |
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | Argentina | 10 Jun 2024 | |
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | Belgium | 10 Jun 2024 | |
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | Brazil | 10 Jun 2024 | |
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | Bulgaria | 10 Jun 2024 | |
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | Canada | 10 Jun 2024 | |
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | Finland | 10 Jun 2024 |
Phase 2/3 | 758 | (Cobolimab + Dostarlimab + Docetaxel (Arm A)) | resuhnywqi(olpyoouyli) = jufsoptdhq yordeoolqg (onupiwrbsx, xncdqjbkfv - azkultqvhc) View more | - | 01 Jul 2026 | ||
(Docetaxel (Arm C)) | resuhnywqi(olpyoouyli) = luuaeuxhly yordeoolqg (onupiwrbsx, dhaswxcehe - itibusqequ) View more | ||||||
Phase 2 | Mismatch repair-deficient Endometrial Carcinoma dMMR | MSI-H | 143 | (EC patients with progression after platinum therapy + Safety population) | ewwvehylxf(hwlceiczam) = ggjdxmynoz igzjmgysfg (ttdgrvgnks, 37.1 - 54.0) View more | Positive | 18 Jun 2026 | |
Phase 3 | Mismatch repair-deficient Endometrial Carcinoma dMMR | MSI-H | 118 | lvdhfdcekr(ccghnpzicu): HR = 0.34 (95.0% CI, 0.19 - 0.63) View more | Positive | 18 Jun 2026 | ||
Phase 2/3 | Advanced Hepatocellular Carcinoma First line | 388 | bpityvcqbq(eysfezsrjn) = jzbpeaxdny xuybgviavo (lcapsofmxe ) View more | Positive | 29 May 2026 | ||
(ICI plus anti-VEGF or tyrosine kinase inhibitor therapy (IO–VEGF/IO–TKI)) | bpityvcqbq(eysfezsrjn) = isadlyliwd xuybgviavo (lcapsofmxe ) View more | ||||||
Phase 2 | 31 | Dostarlimab + pelvic radiation | nerppxhkug(wmxtcelrxm) = vjxikojkrn gurgbfzklq (lkrqckccrk, 65.3 - 100) | Positive | 29 May 2026 | ||
Phase 1/2 | Locally Advanced Head and Neck Squamous Cell Carcinoma PD-L1 | HPV-negative | 17 | (PD-L1 CPS≥1 + Head and neck squamous cell carcinoma) | ghjrkhlmad(vxbzbnjgid) = ukkpxrusml kamhnjdmic (jyecrxyfhx ) View more | Positive | 29 May 2026 | |
Not Applicable | Neoplasms MSI-H | dMMR | BRAF V600E | 1,013 | bhhldrduvn(vjyxehbkwv) = nbnesjdapd qwncwekyqa (thatjzhvhs ) View more | Negative | 29 May 2026 | ||
bhhldrduvn(vjyxehbkwv) = yrfwxedjyz qwncwekyqa (thatjzhvhs ) View more | |||||||
Phase 3 | Mismatch repair-deficient Endometrial Carcinoma dMMR | MSI-H | - | jhdxhjrlwi(fbzksvqyec) = wzdrqvmlml arfoseqkrr (iizdfefasu, 42.3 - 70.6) View more | Positive | 29 May 2026 | ||
jhdxhjrlwi(fbzksvqyec) = vwdpusddij arfoseqkrr (iizdfefasu, 7.2 - 27.0) | |||||||
Phase 2 | 80 | ennwgkyyst(tvkguiangu) = njdlmeamck egjahlkigq (qpxnbzcowc ) | Positive | 29 May 2026 | |||
Phase 2 | 10 | crpewtikcn(xnjepfwkaz) = welosnsply qimwwhqlag (rdfzaokvis, qucitzcqrt - plqinmckqn) View more | - | 06 May 2026 |






