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

Daiichi, AstraZeneca’s Enhertu breaks into early breast cancer with dual FDA approvals

FDA approves Enhertu for two HER2-positive early breast cancer indications

Datopotamab deruxtecan indicated for patients ineligible for immunotherapy

Datroway® Approved in the U.S. as First TROP2 Directed Antibody Drug Conjugate for First-Line Treatment of Patients with…

AstraZeneca and Daiichi Sankyo have secured approval from the US FDA for Datroway (datopotamab deruxtecan) to treat metastatic…

The FDA has approved the TROP2-directed ADC Datroway as a first-line option for triple-negative breast cancer, giving Daiichi…

The TROP2 battle in first-line triple-negative breast cancer has officially kicked off. | A three-way battle among TROP2 ADCs in…

The game is on for TROP2 antibody-drug conjugates in first-line triple-negative breast cancer. | Less than a month after an…