AstraZeneca PLC (AZN), a biopharmaceutical company, and Daiichi Sankyo Company Limited (4568.T), a healthcare company, on Friday announced the approval of Datroway in the treatment of metastatic triple-negative breast cancer by the U.S. Food and Drug Administration (FDA).
Triple-negative breast cancer (TNBC) accounts for 15% of all breast cancers diagnosed, with 345,000 new cases recorded globally every year. Named for the absence of the usual biomarkers of breast cancer - estrogen receptors, progesterone receptors, and HER2- overexpression- the disease shows an overall survival (OS) of 12-18 months. The cancer is diagnosed with the detection of the TROP2 protein in tumors.
Datroway (datopotamab deruxtecan) is a TROP2-targeting Dxd antibody-drug conjugate (ADC), designed using proprietary technology from Daiichi Sankyo. The drug was previously approved by the FDA in 2025 for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC) and received a priority review voucher for the treatment of TNBC.
The approval is supported by results from the global, multicenter, randomized, open-label Phase 3 TROPION Breast 02 trial conducted on 644 TNBC patients who were not candidates for PD-1/PD-L1 inhibitor therapy.
Following treatment with Datroway, a clinically meaningful 5-month improvement in median OS was observed. A 43% reduction in risk of disease progression or death, and an objective response rate (ORR) of 64% was reported.
Datroway is also being evaluated for efficacy in the treatment of NSCLC, and in Phase1/2 trials for the treatment of urothelial cancers.
AZN is currently trading on the NYSE at $187.24, down 1.34%.
4568.T is currently trading on the Tokyo Stock Exchange at ¥2649.50, down 0.56%.
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