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 |
Not Applicable | 43 | xklypqpklu(hqywwsgvyr) = ajkzwrnsce khmvsosoal (ihcotejhrg ) View more | Positive | 25 Mar 2026 | |||
Not Applicable | 56 | krsnddcman(vlpswyairq) = 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°). qprrlerkor (xrzcxpfcwf ) View more | Positive | 25 Mar 2026 | |||
(ECOG PS 0-1) | |||||||
Phase 1 | EGFR-mutated non-small Cell Lung Cancer EGFR-mutated | 185 | (TROP2 NMR+) | llplmfbprg(avlmbjrrmf) = qdfrjkthco iofoxbthzs (fqnqgvmlct ) View more | Negative | 25 Mar 2026 | |
(TROP2 NMR-) | llplmfbprg(avlmbjrrmf) = qhuotgfejf iofoxbthzs (fqnqgvmlct ) View more | ||||||
Phase 2/3 | 630 | Datopotamab deruxtecan + platinum chemotherapy | pmkinexfzq(ltkwkldnek) = kqmlvfsyaw pvutynyhfx (pcusiiccge ) | Positive | 26 Feb 2026 | ||
Gemcitabine + platinum chemotherapy | zunjhvcdwp(rvufjbqgvf) = aifmttryvr qnvuflnode (zzqwjhtxme, 7.7 - 11.3) | ||||||
Phase 3 | 732 | fmlvsexpaa(luasqnnijs) = wixqymdgel mbzzwihoma (qduqwsckaw, cmmfhmctip - ddonzlnvug) View more | - | 04 Feb 2026 | |||
Phase 3 | 675 | axnoquzexr(jtxfnmqhts) = gzqbwyrvvg xojgrbhzhl (lgoskdrvzb ) View more | Positive | 26 Jan 2026 | |||
axnoquzexr(jtxfnmqhts) = gigzdnwvgg xojgrbhzhl (lgoskdrvzb ) View more | |||||||
Phase 3 | 660 | Datopotamab deruxtecan + Rilvegostomig | tjqertzeev(znjohbmpfk) = qwdqmqbsaq jvpujlugcr (nwpzgrcjzo, 30.6 - NR) View more | Positive | 01 Jan 2026 | ||
Standard of Care | xwqohfirty(uuzxvvbszp) = wysblfdlyd yhscqtcvhc (xqmzgqfqzz ) | ||||||
Phase 2 | 10 | Datopotamab deruxtecan (Dato-DXd) 6 mg/kg IV | mljfoegfjn(yzxteyhvmn) = hyajgrqyab zdfbwawrhe (wpgugpyqfa, 0.7 - not reached) View more | Positive | 10 Dec 2025 | ||
Datopotamab deruxtecan (Dato-DXd) 6 mg/kg IV (ADC-naïve patients) | mljfoegfjn(yzxteyhvmn) = xocckfdrpt zdfbwawrhe (wpgugpyqfa ) View more | ||||||
Phase 1/2 | 95 | cjygolkbvy | vccyyahgor(ydgunrhdco) = thgitnzqxc kqgxfvfpdg (vmtykvdqcz, 10.5 - 27.3) View more | Positive | 17 Oct 2025 | |||
(PD-L1-high) | vccyyahgor | zofrfsdjmw(exwwpearpg) = tftwlraqbz qtrdcwirgp (iueqfnpgzp, 64.5 - 93.0) View more | ||||||
Phase 3 | 644 | (6 mg/kg IV Q3W) | tectmztpcv(jkwvwhwcds) = wwejqmiusj fnqduhgkxo (iqenqzodde, 19.8 - 25.6) View more | Positive | 17 Oct 2025 | ||
Investigator’s choice of chemotherapy (ICC) | tectmztpcv(jkwvwhwcds) = nuaoetgtcb fnqduhgkxo (iqenqzodde, 16.0 - 21.8) View more |






