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Datopotamab deruxtecan delivers chemotherapy to cells bearing TROP2. Its FDA approvals cover specific advanced breast-cancer and EGFR-mutated lung-cancer settings.
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.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
Humanised anti-TROP2 IgG1 with DXd; internalisation, lysosomal release, TOP1 inhibition, bystander effect. Connects to TROP2.
1.Antibody binds TROP2 on the tumour cell surface
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. FDA-approved 2025.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments. New product; expect indication-specific policies.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE search: datopotamab deruxtecan. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2020-07-27 | Daiichi Sankyo to AstraZeneca Datopotamab deruxtecan (DS-1062, Datroway) | Co-development | $1.0bn | up to $6.0bn | source |
Would move the TROP2 ADC into the first-line EGFR-mutant setting on top of the standard TKI. Timing is a registry-based estimate. Source
Compare all products across the US, EU, UK, Japan, China and Australia →
HR-positive/HER2-negative unresectable/metastatic breast cancer after endocrine-based therapy and chemotherapy for advanced disease source
First approval worldwide for HR+/HER2- breast cancer (December 2024, Japan MHLW) source
Treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
Accelerated approval: EGFR-mutated advanced NSCLC after EGFR-directed therapy and platinum chemotherapy The confirmatory requirement was still open 1.2 years later, when the FDA's table was read. source
Unresectable/metastatic TNBC when PD-1/PD-L1 therapy is unsuitable; supporting TROPION-Breast02 tested first-line disease source
| Region | Year | Indication |
|---|---|---|
| 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 · https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast |
| US | 2025 | Adults with locally advanced or metastatic EGFR-mutated NSCLC after EGFR-directed therapy and platinum-based chemotherapy · Accelerated approval; https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer |
| US | 2026 | Adults with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor-based therapy · Supporting first-line trial; FDA indication does not specify a prior-line requirement; https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer |
| 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 · https://www.ema.europa.eu/en/medicines/human/EPAR/datroway |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Stomatitis TROPION-Breast01, n=360 | 59% | 7% |
| Nausea TROPION-Breast01, n=360 | 56% | 1.4% |
| Fatigue TROPION-Breast01, n=360 | 44% | 4.2% |
| Alopecia TROPION-Breast01, n=360 | 38% | 0% |
| Constipation TROPION-Breast01, n=360 | 34% | 0.3% |
| Dry eye TROPION-Breast01, n=360 | 27% | 0.8% |
| Keratitis TROPION-Breast01, n=360 | 24% | 1.1% |
| Vomiting TROPION-Breast01, n=360 | 24% | 1.1% |
| Stomatitis (any grade) Datroway label, pooled safety population of 1,365 patients | 63% | - |
| Nausea (any grade) Datroway label, pooled safety population | 51% | - |
Rates read from source 1source 2. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | datroway.com |
| United Kingdom | NICE: appraisal in progress for HR+/HER2- breast cancer; not yet recommended (2026) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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The first-line overall survival result that made an antibody-drug conjugate the standard for PD-L1-negative or immunotherapy-ineligible metastatic triple-negative disease, and the reason the sequencing question (which TROP2 drug first, what after it) is now urgent.
Chinese patients in the trial saw the same pattern as the global population: a clear progression-free survival gain, no proven survival gain, and a different rather than heavier side-effect burden, with mouth and eye toxicity in nearly half. It supports use of datopotamab deruxtecan in this setting in China but does not resolve the global trial's missing survival benefit.
For unresectable or metastatic hormone-receptor-positive, HER2-negative breast cancer after endocrine-based therapy and chemotherapy for advanced disease, Dato-DXd is an FDA-approved option. TROPION-Breast01 showed longer progression-free survival and fewer severe treatment-related adverse events than chemotherapy; the final overall survival analysis did not show a statistically significant improvement. Approval in this setting does not establish a survival advantage or apply to postoperative early-stage disease.
Query for this drug: (TITLE:"Datopotamab deruxtecan" OR ABSTRACT:"Datopotamab deruxtecan" OR TITLE:"Datroway" OR ABSTRACT:"Datroway" OR TITLE:"Dato-DXd" OR ABSTRACT:"Dato-DXd" OR TITLE:"DS-1062" OR ABSTRACT:"DS-1062") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Datopotamab deruxtecan, not a curated reading list.
Shares Living with an antibody-drug conjugate: diarrhoea, blood counts, eyes and lungs, Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer, Require head-to-head trials against the best in class for later entrants, Caution: TOP1 ADC immediately after TOP1 ADC.
Shares TRADE DXd, Noboru Yamamoto, Caution: DXd ADC + agents with pneumonitis risk, Living with an antibody-drug conjugate: diarrhoea, blood counts, eyes and lungs.
Shares Caution: TOP1 ADC immediately after TOP1 ADC, Sequential multiple-assignment randomised trials to find the best order of ADCs, Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial, Topoisomerase-I inhibitor payloads.
Shares EGFR TKI → ADC on progression, Benjamin Besse, Tetrapeptide GGFG (maleimide-GGFG-aminomethyl), DXd.
Shares Neoadjuvant ADC + IO replacing anthracycline chemotherapy in TNBC, ADC for residual disease after KEYNOTE-522, Aditya Bardia, TROP2 PET to choose and sequence TROP2 ADCs.
Shares Aditya Bardia, TROP2 PET to choose and sequence TROP2 ADCs, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, A randomised trial of antibody-drug conjugate sequence in metastatic triple-negative breast cancer.
Shares TROP2 PET → TROP2 ADC selection, TROP2 expression, Topoisomerase-I inhibitor payloads, TROP2 PET to choose and sequence TROP2 ADCs.
Shares ADC for residual disease after KEYNOTE-522, TROPION-Breast03, ctDNA-guided adjuvant decisions after residual disease: escalate the positive, spare the negative, Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point.
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