Datopotamab deruxtecan
Datopotamab deruxtecan (Datroway) is the second TROP2 ADC and shares Enhertu's payload. In 2026 it became a first-line option for triple-negative breast cancer patients who cannot receive immunotherapy.
Approved January 2025 for HR+/HER2- metastatic breast cancer after endocrine and chemotherapy (TROPION-Breast01) and June 2025 for EGFR-mutant NSCLC after TKI and chemotherapy (TROPION-Lung05). In Q2 2026 approved for first-line unresectable/metastatic TNBC in patients ineligible for PD-1/PD-L1 inhibitors based on TROPION-Breast02 (OS 23.7 vs 18.7 months per patient-facing summaries). Lower DAR than T-DXd; stomatitis and ocular surface events are characteristic; ILD occurs. TROPION-Breast05 tests it with durvalumab in PD-L1+ TNBC.
1.Antibody binds TROP2 on the tumour cell surface
- Route
- IV infusion
- Schedule
- 6 mg/kg (maximum 540 mg for ≥90 kg) every 3 weeks
- Dose modifications
- Hold for grade ≥2 stomatitis or ocular events; permanently discontinue for grade ≥2 ILD
- Monitoring
- Oral care with steroid mouthwash prophylaxis; baseline and periodic eye examination; respiratory symptoms
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
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.
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- AstraZeneca Access 360
- AZ&Me Prescription Savings
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- Notes
- MHRA-licensed 2025 for HR-positive/HER2-negative breast cancer; NICE appraisal 2025-26.
Sources: NICE search: datopotamab deruxtecan. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 17 Jan 2025ApprovalUS
HR+/HER2- metastatic breast cancer after endocrine therapy and chemotherapy (TROPION-Breast01) source
- Mar 2025ApprovalJP
First approval worldwide for HR+/HER2- breast cancer (December 2024, Japan MHLW) source
- 23 Jun 2025ApprovalUS
EGFR-mutant NSCLC after TKI and platinum chemotherapy (accelerated) source
- Q2 2026ApprovalUS
First-line unresectable/metastatic TNBC, PD-1/PD-L1 inhibitor ineligible (TROPION-Breast02) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2025 | HR+/HER2- metastatic breast cancer after endocrine therapy and chemotherapy |
| US | 2025 | EGFR-mutant NSCLC after EGFR TKI and platinum chemotherapy |
| US | 2026 | First-line unresectable/metastatic TNBC, PD-1/PD-L1 inhibitor ineligible |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Stomatitis | 59% | 7% |
| Nausea | 56% | 1.4% |
| Fatigue | 44% | 4.2% |
| Alopecia | 38% | 0% |
| Constipation | 34% | 0.3% |
| Dry eye | 27% | 0.8% |
| Keratitis | 24% | 1.1% |
| Vomiting | 24% | 1.1% |
TROPION-Breast01, n=360. Rates read from the US prescribing information. 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.
Trials
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Landmark trials in OnCo
Latest papers
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