Daiichi Sankyo, AstraZeneca apply for second EU approval for Datroway

(Alliance News) - Daiichi Sankyo Co Ltd on Thursday said the EU has validated an application for Datroway as a first-line treatment for patients with metastatic triple negative breast cancer who are not candidates for immunotherapy.

Datroway is an antibody drug conjugate discovered by Tokyo-based pharmaceutical maker Daiichi Sankyo. It is being jointly developed and commercialised with Cambridge, England-based AstraZeneca PLC.

The validation confirms the completion of the application and starts the scientific review process by the European Medicines Agency's Committee for Medicinal Products for Human Use.

In April, the drug was 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 application is based on data from the Tropion-Breast02 phase three trial.

In the trial, Datroway demonstrated a statistically significant and clinically meaningful improvement for overall survival and progression-free survival compared to chemotherapy.

"Datroway has shown the potential to replace traditional chemotherapy and improve survival for patients with metastatic triple negative breast cancer, the most aggressive type of breast cancer with one of the worst prognoses," said Ken Takeshita, head of research & development at Daiichi Sankyo.

"This EMA validation represents the potential for a second indication for Datroway in breast cancer and another step forward in the approval process in Europe."

Daiichi Sankyo said additional regulatory submissions for Datroway in this indication are underway globally.

Shares in Daiichi Sankyo closed down 3.5% at JPY3,341.00 on Thursday in Tokyo. AstraZeneca shares were down 0.6% at 13,476.00 pence in London.

By Michael Hennessey, Alliance News reporter

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