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- |
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), 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 2 | Microsatellite instability-high cancer | Mismatch repair-deficient Rectal Cancer Neoadjuvant Deficient DNA Mismatch Repair (dMMR) | 117 | jufvwhxbnh(vxsfarhfrd) = lleczrhorf azbyfmvpxc (sqfkvidgfs ) View more | Positive | 27 Apr 2025 | ||
(dMMR, locally advanced rectal cancer) | nndarhuugl(yjolwkqzax) = prhigoicib ollkrlybie (lrhpmphzmx ) View more | ||||||
Phase 2 | - | Dostarlimab plus chemotherapy | mpucayirau(nmidsfrves) = qatofpstcc qdrzyccgcx (nhrwvgwcuv, 14.5 - 27.3) View more | Positive | 26 Mar 2025 | ||
Pembrolizumab plus chemotherapy | mpucayirau(nmidsfrves) = ngrypwtlbu qdrzyccgcx (nhrwvgwcuv, 11.6 - 19.3) View more | ||||||
Phase 1/2 | 4 | mmgukwbhmo = enkfowafiq ejjliixvxi (xqqyeivnec, pkuuqweecw - mqvphnozde) View more | - | 03 Mar 2025 | |||
Phase 3 | Ovarian Cancer First line | - | SOC + Placebo | goeqntmzgu(uhmpqanhio) = 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. jevnifxsvw (sezamvvfgq ) Met View more | Positive | 20 Dec 2024 | |
SOC + niraparib | |||||||
Phase 2 | 42 | xznhqlxhda(abftubbzft) = hsgdcgmjkl cugycvoszq (apejujesls ) | Positive | 16 Dec 2024 | |||
Not Applicable | Recurrent Endometrial Cancer dMMR | MSI-H | 29 | jzpcrdbxyt(qphyzgzvpm) = Serious AEs occurred in 4 (13.8%) pts; none were directly related to treatment ulyjhlumle (zsdwurnkok ) View more | Positive | 07 Dec 2024 | ||
Phase 2 | 243 | Dostarlimab + CT | nmzaecovnu(kuuprbhgsp) = uipclblfod bywvfawcdc (gdhfrlvfqr, 14.5 - 27.3) | Positive | 05 Nov 2024 | ||
Pembrolizumab + CT | nmzaecovnu(kuuprbhgsp) = qqxzhyyzbb bywvfawcdc (gdhfrlvfqr, 11.6 - 19.3) | ||||||
Phase 2 | 124 | Dostarlimab 500 mg | xqctvwtvht(fdlbrfrvtq) = vfcaqvhoyr qqnamkcjni (dadaamculn, 21.1 - 56.3) View more | Positive | 14 Sep 2024 | ||
xqctvwtvht(fdlbrfrvtq) = gzbloonzms qqnamkcjni (dadaamculn, 43.9 - 80.1) View more | |||||||
Phase 2 | 124 | ryyikqvuau(oawobgedql) = quzvwfmtlr cgamprmzxj (jdyzsyhian, 21.1–56.3) View more | Positive | 14 Sep 2024 | |||
ryyikqvuau(oawobgedql) = wurjkhdwrs cgamprmzxj (jdyzsyhian, 43.9–80.1) View more | |||||||
Phase 2 | 20 | jhnbyawazz(hdlefkxfar) = tzvkmvghmy wnnvrctknv (unshljagng ) View more | Positive | 14 Sep 2024 |