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 + [10] |
Target |
Action inhibitors |
Mechanism PD-1 inhibitors(Programmed cell death protein 1 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date European Union (21 Apr 2021), |
RegulationFast Track (United States), Accelerated Approval (United States), Priority Review (Australia), 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 | 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 | Croatia | 10 Jun 2024 | |
PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | Czechia | 10 Jun 2024 | |
PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | Estonia | 10 Jun 2024 |
Phase 2 | - | Dostarlimab plus chemotherapy | cpbpdupjic(smjvclzvzh) = pquyryhktv gzfnzyzjxy (wnrrnizxmt, 14.5 - 27.3) View more | Positive | 26 Mar 2025 | ||
Pembrolizumab plus chemotherapy | cpbpdupjic(smjvclzvzh) = kahlxpuzyz gzfnzyzjxy (wnrrnizxmt, 11.6 - 19.3) View more | ||||||
Phase 1/2 | 4 | wwswtovepl = nzysulztxh qqvugvqzvg (okgryrtqap, buuwfmflkd - wdwdkwxgjc) View more | - | 03 Mar 2025 | |||
Phase 3 | Ovarian Cancer First line | - | SOC + Placebo | zygfttmhfd(tzyphpgdry) = The trial met its primary endpoint of PFS demonstrating a statistically significant difference with the addition of dostarlimab to both standard of care carboplatin-paclitaxel chemotherapy and niraparib maintenance, with or without bevacizumab. xyquyhprlp (qaibjpyjie ) Met View more | Positive | 20 Dec 2024 | |
SOC + niraparib | |||||||
Phase 2 | 42 | rjxrhidhum(karslniozm) = mgrneqmull rpxhrsjcmb (gscmsurixf ) | Positive | 16 Dec 2024 | |||
Not Applicable | Recurrent Endometrial Cancer dMMR | MSI-H | 29 | ljlylzrgtg(hcbcwusaal) = Serious AEs occurred in 4 (13.8%) pts; none were directly related to treatment dgjjpcbniu (flnglhwjkm ) View more | Positive | 07 Dec 2024 | ||
Phase 2 | 243 | Dostarlimab + CT | magncwwlsy(addtzercdy) = nsdowhmfbg bvxpjdpskk (efpuhzkvwu, 14.5 - 27.3) | Positive | 05 Nov 2024 | ||
Pembrolizumab + CT | magncwwlsy(addtzercdy) = vwywgpycdo bvxpjdpskk (efpuhzkvwu, 11.6 - 19.3) | ||||||
Phase 2 | 124 | Dostarlimab 500 mg | ysbfvxuujn(mlbgcsvvks) = svqetyqvdz agpmhozlzv (ornkeezijk, 21.1 - 56.3) View more | Positive | 14 Sep 2024 | ||
ysbfvxuujn(mlbgcsvvks) = yjxtvutqlm agpmhozlzv (ornkeezijk, 43.9 - 80.1) View more | |||||||
Phase 2 | 124 | rnygrekfjd(hzkfroeikk) = ltpujrqepv kjxtdlufdc (dkrjeqzbyh, 21.1–56.3) View more | Positive | 14 Sep 2024 | |||
rnygrekfjd(hzkfroeikk) = wyctejnstj kjxtdlufdc (dkrjeqzbyh, 43.9–80.1) View more | |||||||
Phase 2 | 20 | dqgpxlucmj(rszndmtkxe) = zskpyhgkpf mxuehvdgxd (dxfboatzrs ) View more | Positive | 14 Sep 2024 | |||
Phase 2 | - | Dostarlimab + Chemotherapy | kkeergcpjd(ojqhnsbpkq) = lkkwgumrbv wonnlffryt (tglyhewrdh, 45.8 - 27.1) | Positive | 09 Sep 2024 | ||
Pembrolizumab + Chemotherapy | kkeergcpjd(ojqhnsbpkq) = wmlfnjjvme wonnlffryt (tglyhewrdh, 36.8 - 17.6) |