# Datopotamab deruxtecan

Source: https://onco.cc/drugs/datopotamab-deruxtecan/  
OnCo record `datopotamab-deruxtecan` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Datopotamab deruxtecan delivers chemotherapy to cells bearing TROP2. Its FDA approvals cover specific advanced breast-cancer and EGFR-mutated lung-cancer settings.

## Summary

FDA approved datopotamab deruxtecan on January 17, 2025 for adults with unresectable or metastatic HR-positive/HER2-negative breast cancer after endocrine-based therapy and chemotherapy for advanced disease. The June 23, 2025 accelerated approval covers locally advanced or metastatic EGFR-mutated NSCLC after EGFR-directed therapy and platinum chemotherapy. On May 22, 2026 FDA approved unresectable or metastatic TNBC when PD-1/PD-L1 inhibitor therapy is unsuitable; supporting TROPION-Breast02 studied previously untreated advanced disease. It reported median OS 23.7 versus 18.7 months, HR 0.79 (95% CI 0.64 to 0.98), in 644 randomized patients. The label does not require a TROP2 companion test or establish postoperative recurrence prevention. Stomatitis, ocular toxicity and interstitial lung disease require monitoring.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-10-06
- Brand: Datroway
- Code: Dato-DXd, DS-1062
- Modality: ADC
- Mechanism: Humanised anti-TROP2 IgG1 with DXd; internalisation, lysosomal release, TOP1 inhibition, bystander effect.
- Payload: DXd (TOP1 inhibitor), DAR ~4
- Linker: Tetrapeptide GGFG, cleavable
- Approvals: EU 2025: HR+/HER2- mBC after endocrine + chemo; 4 Apr 2025; US 2025: Adults with unresectable or metastatic HR-positive/HER2-negative breast cancer after endocrine-based therapy and chemotherapy for unresectable or metastatic disease; US 2025: Adults with locally advanced or metastatic EGFR-mutated NSCLC after EGFR-directed therapy and platinum-based chemotherapy; US 2026: Adults with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor-based therapy; EU 2025: HR-positive, HER2-negative unresectable or metastatic breast cancer after endocrine therapy and at least one line of chemotherapy; marketing authorisation issued 4 April 2025. No triple-negative indication in the EU on 24 September 2026
- Dosing: IV infusion; 6 mg/kg (maximum 540 mg for ≥90 kg) every 3 weeks
- Toxicity (grade 3+): Stomatitis 7%; Nausea 1.4%; Fatigue 4.2%; Alopecia 0%; Constipation 0.3%; Dry eye 0.8%; Keratitis 1.1%; Vomiting 1.1%

## Notes

- Triple-negative breast cancer biomarkers: TROPION-Breast02 enrolled first-line patients not candidates for PD-1/PD-L1 inhibitors, in practice PD-L1-negative by CPS or IC score or otherwise ineligible, with no TROP2 requirement; TROPION-Breast05 pairs it with durvalumab in PD-L1-positive disease.
- Triple-negative breast cancer, UK and EU status: the US indication (first-line, PD-1 or PD-L1 inhibitor ineligible; Datroway label effective 27 May 2026) has no EU counterpart yet, and in England the NICE appraisal for untreated triple-negative disease (GID-TA11535) and the appraisal for residual disease after neoadjuvant treatment (GID-TA11835, TROPION-Breast03) are both awaiting development. TROPION-Breast02 recruited at nine UK sites (Bristol, Cardiff, Edinburgh, three in London, Northampton, Nottingham and Warwick).

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Datopotamab_deruxtecan
- Current US label: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2950227c-6230-4ca4-a135-46e44d9424a0
- FDA TNBC approval, May 22, 2026: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer
- FDA HR-positive approval, January 17, 2025: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast
- FDA accelerated EGFR-mutant NSCLC approval, June 23, 2025: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer
- Datroway label (openFDA): TNBC indication and TROPION-Breast02 study section: https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22DATROWAY%22
- EMA Datroway product page (HR-positive indication only): https://www.ema.europa.eu/en/medicines/human/EPAR/datroway

## Connected records

- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/), [EGFR-mutated non-small-cell lung cancer](https://onco.cc/cancers/egfr-mutant-nsclc/), [HER2-low and HER2-ultralow metastatic breast cancer](https://onco.cc/cancers/her2-low-metastatic-breast-cancer/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [HR-positive metastatic breast cancer after CDK4/6 inhibitors](https://onco.cc/cancers/hr-positive-metastatic-post-cdk46/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [PD-L1-high non-small-cell lung cancer without a driver mutation](https://onco.cc/cancers/pdl1-high-nsclc/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/), [TROP2 PET](https://onco.cc/technologies/trop2-pet/)
- targets: [TROP2](https://onco.cc/targets/trop2/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/), [Daiichi Sankyo](https://onco.cc/companies/daiichi-sankyo/)
- terms: [DXd](https://onco.cc/terms/dxd/), [Interstitial lung disease (ILD) / pneumonitis](https://onco.cc/terms/ild/), [Living with an antibody-drug conjugate: diarrhoea, blood counts, eyes and lungs](https://onco.cc/terms/adc-side-effects-breast/), [Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point](https://onco.cc/terms/tnbc-residual-disease-decision/), [Tetrapeptide GGFG (maleimide-GGFG-aminomethyl)](https://onco.cc/terms/ggfg/), [Topoisomerase-I inhibitor payloads](https://onco.cc/terms/topoisomerase-i-payloads/)
- trials: [A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer](https://onco.cc/trials/nct06112379/), [A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following C](https://onco.cc/trials/nct06564844/), [A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cance](https://onco.cc/trials/nct06822543/), [A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors](https://onco.cc/trials/nct06130553/), [A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02)](https://onco.cc/trials/nct05460273/), [A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer](https://onco.cc/trials/nct07535437/), [A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer](https://onco.cc/trials/nct03742102/), [A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)](https://onco.cc/trials/nct07098338/), [A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negat](https://onco.cc/trials/nct06508216/), [A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participan](https://onco.cc/trials/nct06417814/), [DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs](https://onco.cc/trials/nct06176261/), [Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)](https://onco.cc/trials/nct05555732/), [DIAMOND](https://onco.cc/trials/diamond/), [Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer](https://onco.cc/trials/nct05061550/), [Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases](https://onco.cc/trials/nct05866432/), [Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell L](https://onco.cc/trials/nct06350097/), [Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations](https://onco.cc/trials/nct05687266/), [Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥](https://onco.cc/trials/nct06357533/), [PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease](https://onco.cc/trials/nct07069595/), [Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer](https://onco.cc/trials/nct07825753/), [Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies](https://onco.cc/trials/nct04644068/), [Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies](https://onco.cc/trials/nct05417594/), [Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)](https://onco.cc/trials/nct05489211/), [Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionab](https://onco.cc/trials/nct05215340/), [TRADE DXd](https://onco.cc/trials/nct06533826/), [TROPION-Breast01](https://onco.cc/trials/tropion-breast01/), [TROPION-Breast02](https://onco.cc/trials/tropion-breast02/), [TROPION-Breast03](https://onco.cc/trials/tropion-breast03/), [TROPION-Breast05](https://onco.cc/trials/tropion-breast05/), [TROPION-Lung01](https://onco.cc/trials/tropion-lung01/), [TROPION-Lung05](https://onco.cc/trials/tropion-lung05/), [TROPION-Lung17](https://onco.cc/trials/nct07291037/)
- key papers: [Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial](https://onco.cc/key-papers/paper-tropion-breast02-ann-oncol-2026/), [TROPION-Breast01 China cohort: datopotamab deruxtecan versus chemotherapy in previously treated HR-positive, HER2-negative breast cancer](https://onco.cc/key-papers/paper-tropion-breast01-china-cohort-esmo-open-2026/), [TROPION-Breast01: datopotamab deruxtecan versus chemotherapy in pretreated hormone-receptor-positive breast cancer, and why a PFS win did not translate to survival](https://onco.cc/key-papers/paper-tropion-breast01-jco-2024/)
- roadmaps: [ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs](https://onco.cc/roadmaps/adc-generations/), [Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem](https://onco.cc/roadmaps/tnbc-roadmap/), [TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET](https://onco.cc/roadmaps/trop2-adc-roadmap/)
- ideas: [A randomised trial of antibody-drug conjugate sequence in metastatic triple-negative breast cancer](https://onco.cc/ideas/idea-tnbc-adc-sequencing-trial/), [ADC for residual disease after KEYNOTE-522](https://onco.cc/ideas/idea-post-neoadjuvant-adc/), [ctDNA-guided adjuvant decisions after residual disease: escalate the positive, spare the negative](https://onco.cc/ideas/idea-tnbc-ctdna-guided-adjuvant-decisions/), [Neoadjuvant ADC + IO replacing anthracycline chemotherapy in TNBC](https://onco.cc/ideas/idea-neoadjuvant-adc-io/), [Patient-derived organoids to pick ADC payloads](https://onco.cc/ideas/idea-organoid-guided-adc/), [Require head-to-head trials against the best in class for later entrants](https://onco.cc/ideas/idea-fund-head-to-head-mandate/), [Sequential multiple-assignment randomised trials to find the best order of ADCs](https://onco.cc/ideas/idea-tr2-smart-sequencing-adc/), [Trials that include, and report, brain metastases in triple-negative breast cancer](https://onco.cc/ideas/idea-tnbc-brain-metastasis-trials/), [TROP2 PET to choose and sequence TROP2 ADCs](https://onco.cc/ideas/idea-trop2-pet-selection/)
- institutions: [Gustave Roussy](https://onco.cc/institutions/gustave-roussy/), [National Cancer Center Hospital](https://onco.cc/institutions/ncc-japan/)
- pairings: [Caution: DXd ADC + agents with pneumonitis risk](https://onco.cc/pairings/ild-overlap-caution/), [Caution: TOP1 ADC immediately after TOP1 ADC](https://onco.cc/pairings/adc-after-adc-caution/), [EGFR TKI → ADC on progression](https://onco.cc/pairings/tki-then-adc-lung/), [TROP2 PET → TROP2 ADC selection](https://onco.cc/pairings/trop2-pet-to-adc/)
- people: [Aditya Bardia](https://onco.cc/people/aditya-bardia/), [Benjamin Besse](https://onco.cc/people/benjamin-besse/), [Joohyuk Sohn](https://onco.cc/people/sohn-joohyuk/), [Noboru Yamamoto](https://onco.cc/people/yamamoto-noboru/), [Sara M. Tolaney](https://onco.cc/people/sara-tolaney/), [Se-Hoon Lee](https://onco.cc/people/lee-se-hoon/)
- bottlenecks: [Incentives reward me-too drugs and marginal gains](https://onco.cc/bottlenecks/b-incentive-misalignment/)
- pathways: [Breast cancer (KEGG map)](https://onco.cc/pathways/breast-cancer-signalling/), [Drug efflux pumps (ABC transporters)](https://onco.cc/pathways/drug-efflux-pumps/)
- biomarkers: [TROP2 expression](https://onco.cc/biomarkers/trop2-expression/)

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