By Fineline Cube 
AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for Datroway (datopotamab deruxtecan) with priority review status for the treatment of adult patients with unresectable or metastatic triple‑negative breast cancer (TNBC) who are ineligible for PD‑1/PD‑L1 inhibitor therapy.
sBLA Details & Current Approvals
| Item | Detail |
|---|---|
| Companies | AstraZeneca / Daiichi Sankyo |
| Drug | Datroway (datopotamab deruxtecan) |
| Mechanism | TROP2‑targeting antibody‑drug conjugate (ADC) |
| sBLA Indication | Unresectable/metastatic TNBC (PD‑1/PD‑L1 ineligible) |
| Review Status | FDA Priority Review |
| Current Approvals | • EGFR‑mutated locally advanced/metastatic NSCLC (accelerated approval) • HR‑positive, HER2‑negative metastatic breast cancer |
Market Impact & Commercial Outlook
- TNBC Market: US TNBC market valued at $1.5 billion : in 2025; represents ~15% : of all breast cancers with limited treatment options for PD‑1/PD‑L1 ineligible patients
- Competitive Landscape: Competes with Gilead’s Trodelvy (TROP2 ADC) and Keytruda combinations; Datroway’s differentiated toxicity profile may offer advantage
- Revenue Potential: Analysts estimate TNBC indication could add $400–600 million to Datroway’s peak sales potential, which currently projects $2 billion : globally across all indications
- Strategic Value: Priority review accelerates potential approval timeline; PDUFA date expected Q3 2026; validates AZ/Daiichi TROP2 platform beyond breast cancer
- Unmet Need: PD‑1/PD‑L1 ineligible TNBC patients represent ~30% : of metastatic population with no approved immunotherapy options
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory review timelines, commercial expectations, and revenue projections for Datroway. Actual results may differ due to FDA review outcomes, competitive dynamics, and market adoption rates.-Fineline Info & Tech