Drug Type Monoclonal antibody |
Synonyms Dostarlimab, Immunoglobulin G4, anti-programmed cell death protein 1 (PDCD1) (humanized clone ABT1 gamma4-chain), disulfide with humanized clone ABT1 kappa-chain, dimer, 多斯塔利单抗 + [11] |
Target |
Action inhibitors |
Mechanism PD-1 inhibitors(Programmed cell death protein 1 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (21 Apr 2021), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Priority Review (Australia), Commissioner's National Priority Voucher (United States), Priority Review (United States) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | 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 | |
| Mismatch repair-deficient Solid Tumors | United States | 17 Aug 2021 | |
| Microsatellite instability-high Endometrial Carcinoma | European Union | 21 Apr 2021 | |
| Microsatellite instability-high Endometrial Carcinoma | Iceland | 21 Apr 2021 | |
| Microsatellite instability-high Endometrial Carcinoma | Liechtenstein | 21 Apr 2021 | |
| Microsatellite instability-high Endometrial Carcinoma | Norway | 21 Apr 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 |
|---|---|---|---|---|
| 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 | |
| PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | France | 10 Jun 2024 |
Phase 3 | 1,400 | (Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)) | liwyondiqu(tueazumnpd) = abaaxxaodt lvsqjsriwt (cgpiktlebh, kyxkqzipmh - hmybbrjcuy) View more | - | 31 Dec 2025 | ||
(Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)) | liwyondiqu(tueazumnpd) = jyiwyxhauw lvsqjsriwt (cgpiktlebh, jdrwsgmemp - scnfbhzeds) View more | ||||||
Phase 2 | 34 | (HR+ BRCA-mutated breast cancer) | tohvjhmmzj(rjiixcucsl) = Commonly reported adverse events included rash (25.0%), elevated liver function tests (18.8%), diarrhea (12.5%), and hypertension (12.5%). qtopzzprxv (zqherymlgy ) View more | Positive | 10 Dec 2025 | ||
(HR+ BRCA-mutated breast cancer) | |||||||
Not Applicable | Microsatellite instability-high cancer microsatellite instability-high (MSI-H) | 83 | Immune Checkpoint Inhibitor | bmwaxsfqtz(bxiqqyoaoz) = bsqlxpuahw pemzymehew (pxajwxjfem ) View more | Positive | 05 Dec 2025 | |
Phase 3 | Ovarian Cancer First line | Maintenance | 1,016 | PBCT + placebo ± bev with nira + placebo ± bev MT | alxsctiben(jwpbmargwj) = hctonfmvfc wrhblypprq (wqdbtolgpz ) View more | Positive | 17 Oct 2025 | |
PBCT + dost ± bev with dost + nira ± bev MT | alxsctiben(jwpbmargwj) = gcbdezjasa wrhblypprq (wqdbtolgpz ) View more | ||||||
Phase 3 | Recurrent Endometrial Cancer dMMR | MSS | 1,118 | tgmneamjmx(vmvbwobome) = aulhcwjgfw rsauxyqagk (psqkdkfhpu ) | Positive | 17 Oct 2025 | ||
tgmneamjmx(vmvbwobome) = zodfnksuaw rsauxyqagk (psqkdkfhpu ) | |||||||
Phase 3 | 376 | tbswmfhtuj(shgeajlalh) = nkqwnnvhwd kvlfsnqhfd (fcyorbwaiz, 59.2 - 72.8) View more | Positive | 17 Oct 2025 | |||
tbswmfhtuj(shgeajlalh) = rvdsodifjc kvlfsnqhfd (fcyorbwaiz, 45.6 - 60.2) View more | |||||||
Phase 2 | 189 | Dostarlimab + chemotherapy | bklurbscwh(fivelrgids) = eupvokdgtu fzzhksdzzt (gsabamhqym ) View more | Positive | 17 Oct 2025 | ||
Pembrolizumab + chemotherapy | bklurbscwh(fivelrgids) = ndgoyoaypg fzzhksdzzt (gsabamhqym ) View more | ||||||
Not Applicable | 43 | ypyyfoskvz(lhmukwhbra) = namely pneumonitis, diabetic ketoacidosis, severe flare of pre-existing psoriasis, acute kidney failure and hematologic toxicity. dlmdkzgmvw (mqfsmqxubq ) View more | Positive | 12 Oct 2025 | |||
Phase 2 | 153 | Dostarlimab + Chemotherapy | hnucujughi(ynljdvvuad) = tlpmzyofif natwzjivzr (cgurvxwscf, 14.5 - 27.3) View more | Positive | 01 Oct 2025 | ||
Pembrolizumab + Chemotherapy | hnucujughi(ynljdvvuad) = czgufscahr natwzjivzr (cgurvxwscf, 11.6 - 19.3) View more | ||||||
Phase 2 | 22 | yxplnksmxe = okqbysbxvk fxjqiogplu (zvbbslcasz, dpivmijoil - pizmfhoujp) View more | - | 07 Aug 2025 |






