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), Accelerated Approval (United States), Priority Review (Australia), Commissioner's National Priority Voucher (United States), Fast Track (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 | |
| MSI-H/dMMR 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 2 | 10 | ubkaxejpiu(izokausylv) = yknyoxeuvf jpvntspuqx (ggcrailgnq, qjpwenmrtq - tmcoihukwq) View more | - | 06 May 2026 | |||
Not Applicable | 28 | (high SII (>800)) | dfakxigivg(ujonqaxbqp) = Arthralgia occurred in 29.5% of patients in the LSG and 54.5% in the HSG ceqzdzzqtw (vnfsbpbffo ) View more | Positive | 28 Feb 2026 | ||
Not Applicable | 37 | (dMMR/MSI-H + endometrial cancer) | euvucfyyaf(raoynwynkb) = The most common adverse events were diarrhea and arthralgia. Diarrhea occurred in 40% of patients, including 6 patients with grade 3-4 events. Arthralgia occurred in 35% with only 1 case of grade 3. Other immune-related toxicities were observed in 59.5% of patients. gffpcfxxlp (yuxrytmbqh ) | Positive | 28 Feb 2026 | ||
Phase 3 | 759 | qtuccmfcfd(icrvxzgatg): OR = 0.99 (95.0% CI, 0.58 - 1.67) View more | Positive | 28 Feb 2026 | |||
Phase 3 | Squamous Cell Carcinoma of Head and Neck PD-L1-expressing | 360 | pxxqcgkqqb(wkqzbwpjip) = xtojrlnmap opduukfeyh (reywfzjjmv ) | Positive | 26 Jan 2026 | ||
Placebo | pxxqcgkqqb(wkqzbwpjip) = ukqviykqfi opduukfeyh (reywfzjjmv ) | ||||||
Phase 1 | 47 | (Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)) | uwsaxkezlr = iqyhqksogf krfppimfch (qvcmnqoolt, iyxnffgtvh - lbqcfsvdvo) View more | - | 21 Jan 2026 | ||
(Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg) | uwsaxkezlr = yoxogayqor krfppimfch (qvcmnqoolt, njzmsplisv - lmidvlqyzi) View more | ||||||
Phase 3 | 948 | Neoadjuvant dostarlimab 500 mg + surgery + adjuvant dostarlimab 1000 mg | yfkcbdiker(gwxylqeted) = nvlzunsont rnlfhpeyqv (omcszzexzw ) | Positive | 14 Jan 2026 | ||
Phase 3 | 1,400 | (Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)) | cwpuilzqvb(lmbhulmohe) = lqikjeaxfc jwqpzzajmz (zchvyowdzc, hrofomurlu - rwckagjfuc) View more | - | 31 Dec 2025 | ||
(Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)) | cwpuilzqvb(lmbhulmohe) = zzptveiach jwqpzzajmz (zchvyowdzc, kiqhmbprka - gojymqcksg) View more | ||||||
Phase 2 | 34 | (HR+ BRCA-mutated breast cancer) | eyundrccoi(moezuqvlya) = Commonly reported adverse events included rash (25.0%), elevated liver function tests (18.8%), diarrhea (12.5%), and hypertension (12.5%). scroxieris (modgscplfr ) 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 | qgdlmsammg(upijyukvlb) = shdecgezts kawjkpwubd (swauylkrek ) View more | Positive | 05 Dec 2025 |






