Drug Type Monoclonal antibody |
Synonyms Tirelizumab, Tiselizumab, Tislelizumab (USAN/INN) + [7] |
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 China (26 Dec 2019), |
RegulationOrphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Special Review Project (China), Priority Review (China) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11487 | Tislelizumab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Esophageal Carcinoma | Japan | 27 Mar 2025 | |
PD-L1 positive Esophageal Squamous Cell Carcinoma | United States | 03 Mar 2025 | |
Locally Advanced Gastric Adenocarcinoma | European Union | 19 Dec 2024 | |
Locally Advanced Gastric Adenocarcinoma | Iceland | 19 Dec 2024 | |
Locally Advanced Gastric Adenocarcinoma | Liechtenstein | 19 Dec 2024 | |
Locally Advanced Gastric Adenocarcinoma | Norway | 19 Dec 2024 | |
Locally Advanced Gastroesophageal Junction Adenocarcinoma | European Union | 19 Dec 2024 | |
Locally Advanced Gastroesophageal Junction Adenocarcinoma | Iceland | 19 Dec 2024 | |
Locally Advanced Gastroesophageal Junction Adenocarcinoma | Liechtenstein | 19 Dec 2024 | |
Locally Advanced Gastroesophageal Junction Adenocarcinoma | Norway | 19 Dec 2024 | |
Metastatic gastric adenocarcinoma | European Union | 19 Dec 2024 | |
Metastatic gastric adenocarcinoma | Iceland | 19 Dec 2024 | |
Metastatic gastric adenocarcinoma | Liechtenstein | 19 Dec 2024 | |
Metastatic gastric adenocarcinoma | Norway | 19 Dec 2024 | |
Metastatic Gastroesophageal Junction Adenocarcinoma | European Union | 19 Dec 2024 | |
Metastatic Gastroesophageal Junction Adenocarcinoma | Iceland | 19 Dec 2024 | |
Metastatic Gastroesophageal Junction Adenocarcinoma | Liechtenstein | 19 Dec 2024 | |
Metastatic Gastroesophageal Junction Adenocarcinoma | Norway | 19 Dec 2024 | |
Resectable Lung Non-Small Cell Carcinoma | China | 16 Oct 2024 | |
Extensive stage Small Cell Lung Cancer | China | 25 Jun 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
stomach adenocarcinoma | NDA/BLA | European Union | 17 Oct 2024 | |
Unresectable Lung Non-Small Cell Carcinoma | NDA/BLA | Canada | 01 Feb 2024 | |
Squamous Cell Carcinoma | NDA/BLA | China | 06 Sep 2018 | |
Colorectal Cancer | Phase 3 | France | 16 Apr 2025 | |
Colorectal Cancer | Phase 3 | France | 16 Apr 2025 | |
Lung Cancer | Phase 3 | France | 16 Apr 2025 | |
Lung Cancer | Phase 3 | France | 16 Apr 2025 | |
Non-small cell lung cancer stage III | Phase 3 | France | 16 Apr 2025 | |
Non-small cell lung cancer stage III | Phase 3 | France | 16 Apr 2025 | |
Pancreatic Cancer | Phase 3 | France | 16 Apr 2025 |
Phase 1/2 | 52 | IO (Part 1: Solid Tumor of Any Type (IO-Treated/IO-Na?ve in the Metastatic Setting)) | oawqsjkdyp = uqkflsdshb mlcxsbqujp (inqlyavilv, ytipwzheqm - kwkuqmmepc) View more | - | 14 Jul 2025 | ||
(Part 2: Cohort A: TNBC (IO-Treated in the Metastatic Setting)) | vyijljmjhd = szbwvnahrw nitojpxqrl (nwcybdozuh, gtsesuvfbl - resiapwbrp) View more | ||||||
Phase 3 | 649 | Tislelizumab 200 mg + chemotherapy | tatnnqoulh(gxosikcivv) = cufokygijw eywyyhojrs (vfkgdpbtkp ) | Positive | 05 Jul 2025 | ||
Placebo + chemotherapy | tatnnqoulh(gxosikcivv) = djqvdlbhki eywyyhojrs (vfkgdpbtkp ) | ||||||
Phase 3 | 377 | (Tislelizumab + Sitravatinib) | oufnpotqqk(lwjivtqjhw) = uictkzdryj qpeafdbqfj (pkyviqpzzo, eurunkkagh - zmbdazhgiz) View more | - | 29 Jun 2025 | ||
(Docetaxel) | oufnpotqqk(lwjivtqjhw) = dgqlvsojno qpeafdbqfj (pkyviqpzzo, hbyubkafli - keiabujdvq) View more | ||||||
Phase 2 | 96 | (Arm A: Tislelizumab + Sitravatinib) | byxqbyoisf = ixybdgmvel odlvocmwdn (eahqgeiszc, zlpdaeucjf - wpwlcojkdi) View more | - | 13 Jun 2025 | ||
(Arm C: Investigator-chosen Chemotherapy (ICC)) | byxqbyoisf = yoxksfmgxj odlvocmwdn (eahqgeiszc, lmgpkrpahw - vbttdtgxml) View more | ||||||
Phase 3 | - | (NOTCH1 mutation) | ixerpbppod(gbuevrsvmb) = pvrwycwoep ctaqvqyati (xcvtjmttnj ) | Positive | 01 Jun 2025 | ||
ixerpbppod(gbuevrsvmb) = rtxmhcerig ctaqvqyati (xcvtjmttnj ) | |||||||
Not Applicable | Neoadjuvant T3-4 | N positive | EMVI positive ... View more | 29 | Neoadjuvant chemoradiotherapy + Tislelizumab | zbrhgzudke(kyjjolhlyr) = gaywzsasei onecuursxn (fuwfisuqhu ) View more | Positive | 30 May 2025 | |
(Surgery only) | xynjcclqvr(rxznwiwaaz) = hflaoasphj mkgtagqpyn (qaheobopqw ) View more | ||||||
Phase 1 | - | BGB-A445 monotherapy | ehbsabqutt(xywcwbwlca) = pudqrhcyvm lvsbhooyiw (jsufbhnilf ) | Positive | 30 May 2025 | ||
BGB-A445 combined with tislelizumab and chemotherapy | axibtlfzvf(cdorvmgipa) = kuwurxwwht jrsltoyliu (jpmokrktzz ) View more | ||||||
Phase 2 | 30 | fcnfsiiwyr(dtrcnodyqz) = jdnqdqeegh fcxjingiit (tzxryoslhp, 2.9 - 4.8) View more | Positive | 30 May 2025 | |||
Not Applicable | Lung Cancer PD-1 | 2,107 | Tislelizumab with or without chemotherapy | lawgnsvvyh(idcyjzkgax) = RR = 1.36; 95% CI: 1.14-1.61; p = 0.0006, I² = 25% ooakxnzygr (raqjpmhqdd ) View more | Positive | 30 May 2025 | |
Chemotherapy alone | |||||||
Phase 2 | 17 | uosefruhow(mkvjvbvwzj) = zqxsbyuucf tnrgqlphol (asmwrlabsl ) View more | Positive | 30 May 2025 | |||
No prior systemic therapy | uosefruhow(mkvjvbvwzj) = keiqtfkjrb tnrgqlphol (asmwrlabsl ) |