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 + [9] |
Target |
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 |
RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Priority Review (AU) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Recurrent Endometrial Cancer | EU | 12 Jan 2024 | |
Recurrent Endometrial Cancer | IS | 12 Jan 2024 | |
Recurrent Endometrial Cancer | LI | 12 Jan 2024 | |
Recurrent Endometrial Cancer | NO | 12 Jan 2024 | |
Advanced Endometrial Carcinoma | EU | 12 Dec 2023 | |
Advanced Endometrial Carcinoma | IS | 12 Dec 2023 | |
Advanced Endometrial Carcinoma | LI | 12 Dec 2023 | |
Advanced Endometrial Carcinoma | NO | 12 Dec 2023 | |
Mismatch repair-deficient Solid Tumors | US | 17 Aug 2021 | |
Microsatellite instability-high Endometrial Carcinoma | EU | 21 Apr 2021 | |
Microsatellite instability-high Endometrial Carcinoma | IS | 21 Apr 2021 | |
Microsatellite instability-high Endometrial Carcinoma | LI | 21 Apr 2021 | |
Microsatellite instability-high Endometrial Carcinoma | NO | 21 Apr 2021 | |
Mismatch repair-deficient Endometrial Carcinoma | EU | 21 Apr 2021 | |
Mismatch repair-deficient Endometrial Carcinoma | IS | 21 Apr 2021 | |
Mismatch repair-deficient Endometrial Carcinoma | LI | 21 Apr 2021 | |
Mismatch repair-deficient Endometrial Carcinoma | NO | 21 Apr 2021 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | JP | 10 Jun 2024 | |
PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | AR | 10 Jun 2024 | |
PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | BE | 10 Jun 2024 | |
PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | BR | 10 Jun 2024 | |
PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | BG | 10 Jun 2024 | |
PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | CA | 10 Jun 2024 | |
PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | HR | 10 Jun 2024 | |
PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | CZ | 10 Jun 2024 | |
PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | EE | 10 Jun 2024 | |
PD-L1 positive Non-Small Cell Lung Cancer | Phase 3 | FI | 10 Jun 2024 |
NCT04165772 (ASCO2024) Manual | Phase 2 | Mismatch repair-deficient Rectal Cancer Neoadjuvant | 41 | zxxmqcqanu(mwufbnfvin) = oynpbfzbdy kgxmyxausb (efoqvmqijg ) Met View more | Positive | 02 Jun 2024 | |
Not Applicable | - | cbdubghuyk(dgmljwyzmm) = acceptable safety profile in line with the TIGIT:PD-1 class vdcboixoiy (ifmijraqqa ) | Positive | 10 May 2024 | |||
Phase 2 | Platinum-Resistant Ovarian Carcinoma BRCA | HRD | PD-L1 | 41 | ouwicsbjfd(buuvgudlhy) = tosvtoaaqu hcfbceuvee (tlmhvsxttj, 9.8 - 27.0) View more | Negative | 01 May 2024 | ||
Phase 3 | - | rchfzxyvom(jnvnjwwgmw) = ffxccaxxxo iwzfljopso (gmsbyyxryi ) Met View more | Positive | 16 Mar 2024 | |||
Placebo+chemotherapy+placebo | rchfzxyvom(jnvnjwwgmw) = ndbtbnjmdc iwzfljopso (gmsbyyxryi ) Met View more | ||||||
Phase 3 | Endometrial Carcinoma Microsatellite Stable (MSS) | Proficient DNA Mismatch Repair (pMMR) | MSI-High | ... View more | - | mkxlurxsxw(oblgxuysik) = fstrikmffr juepomzxxc (oghgitqhjb, 32.6–NR) Met View more | Positive | 16 Mar 2024 | ||
mkxlurxsxw(oblgxuysik) = jftpxyaytx juepomzxxc (oghgitqhjb, 22.1–35.6) Met View more | |||||||
RUBY (NEWS) Manual | Phase 3 | Advanced Endometrial Carcinoma Maintenance | - | Jemperli +Zejula | rsujlpmhrv(wcjectycpo) = significantly improved progression-free survival (PFS) versus placebo maaqifucsb (dmzgtmwlgx ) | Positive | 18 Dec 2023 |
placebo | |||||||
Phase 1 | 14 | ysnqonrrtg(zzvhkmhtam) = sjvdxmyyka cgzkhvqtzo (iiyoekbpcq ) | - | 07 Dec 2023 | |||
Chemotherapy | ysnqonrrtg(zzvhkmhtam) = exdxamorpu cgzkhvqtzo (iiyoekbpcq ) | ||||||
Phase 2 | Metastatic Non-Squamous Non-Small Cell Lung Carcinoma First line PD-L1 status | EGFR | ALK ... View more | 243 | Dostarlimab + CT | oswiexywcw(nxwmgkklyw) = tpwcyarfnq vamfctckxb (nmurqddbtc ) | Positive | 02 Dec 2023 | |
Pembrolizumab + CT | oswiexywcw(nxwmgkklyw) = erbhstkyug vamfctckxb (nmurqddbtc ) | ||||||
Phase 1 | 327 | brvkwnakxf(mccluedzst) = jgaifhikjr cyrmkheohy (lgbaxupsfd, 38.6 - 49.6) View more | Positive | 24 Nov 2023 | |||
Phase 3 | - | Dostarlimab+chemotherapy | irxxrerqgt(kfqvotueby) = The trial met its primary endpoint of overall survival, demonstrating a statistically significant and clinically meaningful benefit in the overall patient population. wetixdykib (fbeiujxgto ) Met View more | Positive | 30 Oct 2023 | ||
Placebo+chemotherapy |