May 22, 2026
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The FDA approved datopotamab deruxtecan-dlnk as the first TROP2-directed antibody drug conjugate for first-line treatment of unresectable or metastatic triple-negative breast cancer in patients ineligible for PD-1/PD-L1 inhibitor therapy.The agency granted priority review and approved datopotamab deruxtecan (Datroway; AstraZeneca, Daiichi Sankyo) based on results from the phase 3 TROPION-Breast02
May 22, 2026
2 min read
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New First-Line Option Approved in Triple-Negative Breast Cancer

Datroway® Approved in the U.S. as First TROP2 Directed Antibody Drug Conjugate for First-Line Treatment of Patients with Metastatic Triple Negative Breast Cancer Who Are Not PD-1/PD-L1 Inhibitor Candidates

AstraZeneca, Daiichi Sankyo's Datroway receives FDA approval for TNBC

FDA grants Daiichi Sankyo and AstraZeneca’s Datroway a key breast cancer approval

AstraZeneca, Daiichi beat Gilead to first-line TNBC with FDA nod for Datroway

Blockbuster Drug Gets Breast Cancer Approvals in Curative Setting