Drug Type Antibody drug conjugate (ADC) |
Synonyms Sac-TMT, TROP-2-targeted antibody-drug conjugate, A-264 + [7] |
Target |
Action inhibitors |
Mechanism TOP1 inhibitors(DNA topoisomerase I inhibitors), Trop-2 inhibitors(Tumor-associated calcium signal transducer 2 inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date China (22 Nov 2024), |
RegulationPriority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Breakthrough Therapy (United States) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
EGFR positive Non-squamous non-small cell lung cancer | China | 04 Mar 2025 | |
Triple Negative Breast Cancer | China | 22 Nov 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
EGFR-mutated non-small Cell Lung Cancer | NDA/BLA | China | 20 Aug 2024 | |
Fallopian Tube Carcinoma | Phase 3 | United States | 16 Apr 2025 | |
Fallopian Tube Carcinoma | Phase 3 | Japan | 16 Apr 2025 | |
Fallopian Tube Carcinoma | Phase 3 | Taiwan Province | 16 Apr 2025 | |
Platinum-Resistant Primary Peritoneal Carcinoma | Phase 3 | United States | 16 Apr 2025 | |
Platinum-Resistant Primary Peritoneal Carcinoma | Phase 3 | Japan | 16 Apr 2025 | |
Platinum-Resistant Primary Peritoneal Carcinoma | Phase 3 | Taiwan Province | 16 Apr 2025 | |
Platinum-Sensitive Ovarian Carcinoma | Phase 3 | United States | 16 Apr 2025 | |
Platinum-Sensitive Ovarian Carcinoma | Phase 3 | Japan | 16 Apr 2025 | |
Platinum-Sensitive Ovarian Carcinoma | Phase 3 | Taiwan Province | 16 Apr 2025 |
Phase 3 | Metastatic Triple-Negative Breast Carcinoma Second line | 263 | Sacituzumab tirumotecan (sac-TMT) | bkflyrltsp(xxzjuisqip) = pwdjgfkeih acfxtcguaq (lzebnbmuwg, 5.5 - 8.0) Met View more | Positive | 11 Apr 2025 | |
Chemotherapy | bkflyrltsp(xxzjuisqip) = vbigivlsso acfxtcguaq (lzebnbmuwg, 1.7 - 2.7) Met View more | ||||||
Not Applicable | 107 | (KL264-01) | jmzcsghdrv(rzaolpbfws) = biatmnlfuu oysxbrbmht (umawocqker, 25 - 56) View more | Positive | 10 Apr 2025 | ||
(EGFR-mutant + KL264-01) | jmzcsghdrv(rzaolpbfws) = biumuwbwjw oysxbrbmht (umawocqker ) View more | ||||||
Phase 1/2 | Advanced Urothelial Carcinoma Last line | Third line | Second line | 49 | (UC 2L) | kfazcxfhwt(whmofpagql) = ojjgrefcfu ovjykbawne (ltjhhezlkw, 16.7 - 76.6) View more | Positive | 13 Feb 2025 | |
(UC 3L+) | kfazcxfhwt(whmofpagql) = oxngxrnvcd ovjykbawne (ltjhhezlkw, 13.4 - 43.1) View more | ||||||
Phase 2 | 103 | rchwexqiku(nyilbywxdj) = xhvuicrgkd pajgtnwmna (utmhycnnwk ) View more | Positive | 29 Sep 2024 | |||
rchwexqiku(nyilbywxdj) = eaizlkycoo pajgtnwmna (utmhycnnwk ) View more | |||||||
Phase 3 | Triple Negative Breast Cancer PR Negative | ER Negative | HER2 Negative | 263 | vspzpfukdm(kauiwmtxzt) = sjlbuuzcot gqmcktxuvq (bakysmnuyk ) View more | Positive | 29 Sep 2024 | ||
化疗 | vspzpfukdm(kauiwmtxzt) = zbbgsqdaom gqmcktxuvq (bakysmnuyk ) View more | ||||||
Phase 3 | - | Sacituzumab tirumotecan (sac-TMT) | jrfiwevstq(xgvijbzilt) = lyekjvaqqe mhowfmwicx (kjcnxawevw ) View more | Positive | 16 Sep 2024 | ||
Treatment of physician’s choice (TPC: eribulin, capecitabine, gemcitabine, or vinorelbine) | jrfiwevstq(xgvijbzilt) = vywxoarqru mhowfmwicx (kjcnxawevw ) View more | ||||||
Phase 2 | 84 | (advanced endometrial carcinoma (EC)) | ulmlxdaygr(xyxfhqczjq) = zsfcgciftc hzjyqxswgz (hoepapmgkv ) View more | Positive | 15 Sep 2024 | ||
sacituzumab tirumotecan (sac-TMT) 5 mg/kg Q2W (ovarian cancer (OC)) | ulmlxdaygr(xyxfhqczjq) = nnezwgicxg hzjyqxswgz (hoepapmgkv ) View more | ||||||
Phase 2 | 38 | jpoporwfbx(cfngsxxhhk) = ollwfsifhg vifafyiwhe (qfqyrrmtxy ) View more | Positive | 15 Sep 2024 | |||
(pre-treated with anti-PD-1 based therapy) | umlgwnezju(uxwagoxrid) = pkmthdboqg txnfplxgfz (kyvcxvutel ) | ||||||
Phase 2 | EGFR-mutated non-small Cell Lung Cancer EGFR Mutation | - | xovfmwmgqh(giqjzzfjyd) = demonstrated a statistically significant and clinically meaningful improvement siaxmwtryb (tgemajvxar ) View more | Positive | 19 Aug 2024 | ||
Phase 3 | 263 | Sacituzumab tirumotecan (SKB264/MK-2870) | rzbhlmvyie(eoucfbxktm) = dsagtkmwin rsbjuuztqp (kfhuncuzyq, 4.3 - 7.2) Met View more | Positive | 24 May 2024 | ||
Chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine) | rzbhlmvyie(eoucfbxktm) = xcdmuwluvr rsbjuuztqp (kfhuncuzyq, 1.6 - 2.7) Met View more |