AstraZeneca's and Daiichi's Datroway wins EU breast cancer approval
(Alliance News) - AstraZeneca PLC on Friday said the European Commission has approved Datroway for the first-line treatment of some patients with an aggressive form of breast cancer.
The Cambridge, England-based pharmaceutical company said Datroway, developed with Daiichi Sankyo Co Ltd, was approved as a monotherapy for adults with unresectable or metastatic triple-negative breast cancer who are not eligible for PD-1 or PD-L1 inhibitor immunotherapy.
AstraZeneca said Datroway is the only TROP2-directed medicine approved in the European Union to have demonstrated an overall survival benefit in this first-line setting.
The approval was based on results from the phase-three Tropion-Breast02 trial, in which Datroway improved median overall survival by five months compared with chemotherapy.
Median overall survival was 23.7 months for patients receiving Datroway, compared with 18.7 months for those treated with chemotherapy.
Datroway also reduced the risk of disease progression or death by 43% and achieved an objective response rate of 62.5%, compared with 29.3% for chemotherapy.
AstraZeneca Executive Vice President Dave Fredrickson said: "Today's approval of Datroway brings an antibody drug conjugate with a differentiated clinical profile underpinned by a strong survival benefit to people with this aggressive disease."
The drug is now approved for two breast cancer indications in the EU. It received US approval for the same indication in May, while regulatory reviews are ongoing in China, Japan, Australia, Canada, Singapore and Switzerland.
Shares in AstraZeneca were 0.8% higher at 12,820.00 pence in London on Friday morning.
Daiichi's shares closed down 11% to JPY2,567.50 in Tokyo, after reporting a 20% fall in profit in the first quarter, and cutting its profit outlook.
By Eva Castanedo, Alliance News senior economics reporter
Comments and questions to newsroom@alliancenews.com
Copyright 2026 Alliance News Ltd. All Rights Reserved.
The articles, information, and content displayed on this webpage may include materials prepared and provided by third parties. Such third-party content is offered for informational purposes only and is not endorsed, reviewed, or verified by Morningstar.
Morningstar makes no representations or warranties regarding the accuracy, completeness, timeliness, or reliability of any third-party content displayed on this site. The views and opinions expressed in third-party content are those of the respective authors and do not necessarily reflect the views of Morningstar, its affiliates, or employees.
Morningstar is not responsible for any errors, omissions, or delays in this content, nor for any actions taken in reliance thereon. Users are advised to exercise their own judgment and seek independent financial advice before making any decisions based on such content. The third-party providers of this content are not affiliated with Morningstar, and their inclusion on this site does not imply any form of partnership, agency, or endorsement.
Popular
5 Stocks to Buy Trading at Big Discounts
2 Undervalued Stocks to Buy With Long-Term Growth Ahead
The Market May Be Too Pessimistic About This 4-Star Dividend Stock
What 7 Key Market Indicators Are Telling Investors Right Now
United States