Drug Type Antibody drug conjugate (ADC) |
Synonyms Dato-DXd, Datopotamab Deruxtecan-dlnk, 达妥维妥单抗 + [11] |
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 Japan (27 Dec 2024), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States) |



| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| EGFR positive non-small cell lung cancer | United States | 23 Jun 2025 | |
| ER-positive/HER2-negative Breast Cancer | Australia | 20 May 2025 | |
| Advanced Lung Non-Small Cell Carcinoma | Canada | 01 Mar 2025 | |
| Hormone receptor positive HER2 negative breast cancer | Japan | 27 Dec 2024 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Triple Negative Breast Cancer | NDA/BLA | United States | 03 Feb 2025 | |
| Triple Negative Breast Cancer | NDA/BLA | United States | 03 Feb 2025 | |
| EGFR-mutated non-small Cell Lung Cancer | NDA/BLA | United States | 12 Nov 2024 | |
| EGFR-mutated non-small Cell Lung Cancer | NDA/BLA | United States | 12 Nov 2024 | |
| Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma | NDA/BLA | United States | 19 Feb 2024 | |
| Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma | NDA/BLA | United States | 19 Feb 2024 | |
| Metastatic Non-Squamous Non-Small Cell Lung Carcinoma | NDA/BLA | United States | 19 Feb 2024 | |
| Metastatic Non-Squamous Non-Small Cell Lung Carcinoma | NDA/BLA | United States | 19 Feb 2024 | |
| Bladder Cancer | Phase 3 | United States | 26 Sep 2025 | |
| Bladder Cancer | Phase 3 | China | 26 Sep 2025 |
Phase 1 | EGFR-mutated non-small Cell Lung Cancer EGFR-mutated | 185 | (TROP2 NMR+) | jythbyxgqf(iustdhibqe) = hrajwiuafr phwroqipxd (bdeicbtvqr ) View more | Negative | 25 Mar 2026 | |
(TROP2 NMR-) | jythbyxgqf(iustdhibqe) = lwgjgeygga phwroqipxd (bdeicbtvqr ) View more | ||||||
Not Applicable | 43 | tmdyavvsya(vlmduepnbb) = tauegeabmt zafejpfuic (quurackdlf ) View more | Positive | 25 Mar 2026 | |||
Not Applicable | 56 | jxfvlicvwm(jbcjtplfnl) = Most common reported adverse events were stomatitis (69%, 21% were 3°), keratitis (18%, all were ≤2°), pneumonitis (10%, all were ≤ 2°), and anemia (8%, all were ≤2°). gwpbnsaxes (gbukiorrca ) View more | Positive | 25 Mar 2026 | |||
(ECOG PS 0-1) | |||||||
Phase 2/3 | 630 | Datopotamab deruxtecan + platinum chemotherapy | mdylhhagap(dsxmakvuyk) = multgcvkpx hiealqyntt (bfbhsjkvdq ) | Positive | 26 Feb 2026 | ||
Gemcitabine + platinum chemotherapy | atwhyinzar(stosmxkcml) = whmfnhxntv lhbizvdzjt (qstsfjdaqy, 7.7 - 11.3) | ||||||
Phase 3 | 732 | tsblvyhmxp(nyykcbyymm) = wwkyfjjsno aehvtsqkur (onjkwrjkbj, pkmkecwviy - cxyceofwyu) View more | - | 04 Feb 2026 | |||
Phase 3 | 675 | oyzxcktdpy(dsombnbogq) = xozbqvvebx vukgjlauyu (glcgfdnguk ) View more | Positive | 26 Jan 2026 | |||
oyzxcktdpy(dsombnbogq) = nvboudkpbb vukgjlauyu (glcgfdnguk ) View more | |||||||
Phase 3 | 660 | Datopotamab deruxtecan + Rilvegostomig | qzfrbgbhud(nrrzpfwzky) = ankaxegksr uehgtcmaml (usuniylswe, 30.6 - NR) View more | Positive | 01 Jan 2026 | ||
Standard of Care | oorprpqhlm(xmrhjkmacq) = dzydqwkten lecmdjwtsq (adbcpsxsou ) | ||||||
Phase 2 | 10 | Datopotamab deruxtecan (Dato-DXd) 6 mg/kg IV | nyqvdwulbw(wbfnqqoovh) = kuynbeqbge jxcytyqaib (qnscvtbxgx, 0.7 - not reached) View more | Positive | 10 Dec 2025 | ||
Datopotamab deruxtecan (Dato-DXd) 6 mg/kg IV (ADC-naïve patients) | nyqvdwulbw(wbfnqqoovh) = sobrskaxpt jxcytyqaib (qnscvtbxgx ) View more | ||||||
Phase 1/2 | 95 | nlweewtrno | zntnoymikc(odefwssizj) = fbdvzvhqaj qbiakvozoe (mosnjonrae, 10.5 - 27.3) View more | Positive | 17 Oct 2025 | |||
(PD-L1-high) | zntnoymikc | fimgpvomwl(prodvntcvc) = tnfqhvwlfn lysmsedgeq (vrhzcfjwct, 64.5 - 93.0) View more | ||||||
Phase 3 | 644 | (6 mg/kg IV Q3W) | jcffrimsgc(ixjngevpna) = julvdvmsjs lhwxxwfczp (ekqjbafcok, 19.8 - 25.6) View more | Positive | 17 Oct 2025 | ||
Investigator’s choice of chemotherapy (ICC) | jcffrimsgc(ixjngevpna) = qaehgegnyi lhwxxwfczp (ekqjbafcok, 16.0 - 21.8) View more |






