Datroway US approval in first-line metastatic TNBC announced

22 May 2026

AstraZeneca (LSE: AZN) and Daiichi Sankyo (TYO: 4568) have secured US approval for Datroway (datopotamab deruxtecan-dlnk) as a first-line treatment for patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor therapy.

The approval marks a significant expansion for the TROP2-directed antibody-drug conjugate (ADC) and positions the therapy as the first drug in its class approved in this setting. It also intensifies competition in the rapidly growing ADC market, particularly against Gilead Sciences’ (Nasdaq: GILD) Trodelvy (sacituzumab govitecan-hziy).

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