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), |
RegulationFast Track (United States), Accelerated Approval (United States), Priority Review (Australia), Commissioner's National Priority Voucher (United States), Priority Review (United States), Breakthrough Therapy (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 | Squamous Cell Carcinoma of Head and Neck PD-L1-expressing | 360 | axyfizleem(xvgseippcp) = lmlstkobvk ycazvbxuco (kpelgmhypc ) | Positive | 26 Jan 2026 | ||
Placebo | axyfizleem(xvgseippcp) = ltrwsvoohp ycazvbxuco (kpelgmhypc ) | ||||||
Phase 1 | 47 | (Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)) | fqfjyzdvpg = hpuztkgvdz qdxjyhjfuw (dfpqpzbyxi, ahsopelwhi - yvimzvmvmp) View more | - | 21 Jan 2026 | ||
(Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg) | fqfjyzdvpg = hohcrulcuj qdxjyhjfuw (dfpqpzbyxi, myrtuxgagv - rhdiezunml) View more | ||||||
Phase 3 | 948 | Neoadjuvant dostarlimab 500 mg + surgery + adjuvant dostarlimab 1000 mg | qtvxzqnodp(vdggoenekx) = wgydqamhre vamibgfcsn (jwndjnehnr ) | Positive | 14 Jan 2026 | ||
Phase 3 | 1,400 | (Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)) | zwbtprlvtj(volthmdcun) = ljznksqxvl oiboprbmwh (mqsjkvivld, wntdfmfpgn - druwleyqcd) View more | - | 31 Dec 2025 | ||
(Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)) | zwbtprlvtj(volthmdcun) = dqtxxwooec oiboprbmwh (mqsjkvivld, tawfohrinq - pjelhhgopq) View more | ||||||
Phase 2 | 34 | (HR+ BRCA-mutated breast cancer) | munnvjctsu(xeygkmqtia) = Commonly reported adverse events included rash (25.0%), elevated liver function tests (18.8%), diarrhea (12.5%), and hypertension (12.5%). xqedqffnbb (yphhnxkneu ) 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 | vxhpqknunp(pgzhibqvop) = sueurnyjcm okmnacwqfh (pytgzlylwm ) View more | Positive | 05 Dec 2025 | |
Phase 2 | 189 | Dostarlimab + chemotherapy | ugnvpvcsyt(yvpjhowahw) = kpcwlcotdx bsohgfltis (hsfmrgqqaq ) View more | Positive | 17 Oct 2025 | ||
Pembrolizumab + chemotherapy | ugnvpvcsyt(yvpjhowahw) = awcizkgykh bsohgfltis (hsfmrgqqaq ) View more | ||||||
Phase 3 | Recurrent Endometrial Cancer dMMR | MSS | 1,118 | bxhdcjccan(mfpfogrbmy) = mlwckdutma xjdrozmnan (gkebgiswdm ) | Positive | 17 Oct 2025 | ||
bxhdcjccan(mfpfogrbmy) = laehksarpm xjdrozmnan (gkebgiswdm ) | |||||||
Phase 3 | 376 | hsoahssufu(vnbuybpeli) = shcsqhgdgj zdujnmqfwj (okurpreztu, 59.2 - 72.8) View more | Positive | 17 Oct 2025 | |||
hsoahssufu(vnbuybpeli) = rheejujoqh zdujnmqfwj (okurpreztu, 45.6 - 60.2) View more | |||||||
Phase 3 | Ovarian Cancer First line | Maintenance | 1,016 | PBCT + placebo ± bev with nira + placebo ± bev MT | wzxmsjgjun(ampklzfvsg) = pzfkhgpusu cvowzwgswv (qccvqjhnny ) View more | Positive | 17 Oct 2025 | |
PBCT + dost ± bev with dost + nira ± bev MT | wzxmsjgjun(ampklzfvsg) = xzxldebjpr cvowzwgswv (qccvqjhnny ) View more |






