9th Apr 2025 05:58
(Alliance News) - Daiichi Sankyo Co Ltd and AstraZeneca PLC on Tuesday said Datroway has secured EU approval to treat breast cancer patients.
Daiichi Sankyo, a Tokyo-based pharmaceutical company, and AstraZeneca, a Cambridge-based pharmaceutical firm agreed to jointly develop and commercialise Datroway in July 2020.
Daiichi Sankyo is responsible for the manufacturing and supply of Datroway and retains exclusive rights for the treatment in the Japanese market.
Datroway, also known as datopotamab deruxtecan, is an antibody drug conjugate.
The treatment has now been approved in the EU to treat adult patients with unresectable or metastatic hormone receptor positive, HER2 negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting.
The approval by the European Commission is based on phase 3 trial results and follows the positive opinion of the Committee for Medical Products for Human Use of the European Medicines Agency.
In trials, Datroway was found to significantly reduce the risk of disease progression or death by 37% compared with chemotherapy.
"Datroway represents the second antibody drug conjugate approved for breast cancer based on Daiichi Sankyo's DXd technology and the third medicine to be approved in the EU from our oncology pipeline, underscoring our commitment to creating new medicines for patients with cancer," commented Global Head of Oncology Ken Keller.
Datroway is now approved in more than 30 countries.
Daiichi Sankyo shares were down 5.7% at JPY3,164.00 each in Tokyo on Wednesday afternoon.
AstraZeneca shares closed 3.4% higher at 10,400.00 pence each in London on Tuesday, while in New York shares closed down 1.4% at USD64.90 each before falling 1.4% after hours.
By Elijah Dale, Alliance News reporter
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