31st Jul 2026 09:49
(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
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