# Datroway by Daiichi Sankyo

Canonical page: https://technooptimist.io/biotech/datroway
Frontier: [Biotech](https://technooptimist.io/biotech.md) · Field: Antibody drugs · Company: [Daiichi Sankyo](https://technooptimist.io/companies/daiichi-sankyo.md)
Stage: Deploy (4 of 5: Research → Proto → Pilot → Deploy → Scaling)
Updated: last update 2026-05-22, facts checked 2026-10-11
Goal: Bring the DXd payload to the many cancers that lack HER2 but carry TROP2, starting with triple-negative breast cancer, the subtype with the fewest targeted options and the worst survival.
Status: Three US approvals; May 2026 first-line triple-negative breast cancer after a survival win.
Next milestone: EU, China and Japan reviews in triple-negative breast cancer, target 2026

## Milestones

| Status | Milestone | Date | Slip |
| --- | --- | --- | --- |
| Done | AstraZeneca co-development deal | Jul 2020 |   |
| Done | TROPION-Breast02 results presented (ESMO) | 2025 |   |
| Done | FDA: first-line triple-negative breast cancer | 22 May 2026 |   |
| Current | EU, China and Japan reviews in triple-negative breast cancer | 2026 |   |

## Upcoming events

- **2026**: EU, China and Japan reviews in triple-negative breast cancer

## Most important updates

- **22 May 2026**: Datroway approved in the US for first-line triple-negative breast cancer after extending survival. The FDA approved Datroway for metastatic triple-negative breast cancer in patients who cannot receive PD-1/PD-L1 immunotherapy. ([our story](https://technooptimist.io/stories/datroway-approved-in-the-us-for-first-line-triple-negative-breast-6f00b0bf.md) · [original source](https://www.astrazeneca.com/media-centre/press-releases/2026/datroway-approved-in-us-for-1l-triple-negative-bc.html))

## Current obstacles

- **Mouth and eye side effects**: Label warns of stomatitis, eye problems and lung inflammation, linked to TROP2 on normal epithelia.
- **Crowded TROP2 field**: Gilead's Trodelvy and Merck's sac-TMT target the same protein; Datroway must win on survival or safety.

## Physics limits

- **TROP2 is also on healthy surfaces**: Skin, mouth and eye linings carry TROP2, so the drug inevitably hits them; that on-target toxicity limits the dose and the payload loading.

## How it works

### Antibody: Humanised anti-TROP2

Docks on TROP2, a cell-surface protein found on most breast and lung cancers; developed with Sapporo Medical University.

### Payload: Same DXd as Enhertu

A cleavable linker releases the topoisomerase I poison DXd inside the cell, breaking DNA as it divides.

## Spec sheet

| Spec | Datroway | Provenance |
| --- | --- | --- |
| Survival in 1st-line TNBC (TB-02) | +5.0 months (HR 0.79) | reported |
| Progression-free survival HR | 0.57 | reported |
| Response rate vs chemo | 64% vs 30% | reported |
| US indications | 3 | reported |
| Dose | 6 mg/kg every 3 weeks | reported |

Provenance: reported = stated by the company; estimated = our estimate; sample = a sample figure.

## About Daiichi Sankyo

Japanese drugmaker whose DXd technology produced the most successful antibody-drug conjugates: Enhertu (HER2) and Datroway (TROP2), both co-developed and sold with AstraZeneca.

- Enhertu is approved in 90+ countries for HER2-positive breast cancer and now used from early disease to first-line metastatic.
- Datroway won a survival benefit in first-line triple-negative breast cancer; US approval May 2026.
- AstraZeneca partnerships: Enhertu since March 2019, Datroway since July 2020; Daiichi keeps Japan and makes the drugs.

- Headquarters: JP
- Status: public
- Website: https://www.daiichisankyo.com
- Partners, customers, investors: AstraZeneca (partner)

Company page: https://technooptimist.io/companies/daiichi-sankyo.md

## Related programs

More from Daiichi Sankyo:

- [Enhertu](https://technooptimist.io/biotech/enhertu.md) (Scaling)

Everything in Biotech: https://technooptimist.io/biotech.md

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