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AstraZeneca And Daiichi Sankyo's Enhertu Approved In EU For Breast Cancer

AstraZeneca Plc. (AZN.L,AZN) and Daiichi Sankyo Company Limited (DSKYF.PK) said that the European Union has conditionally approved Enhertu or trastuzumab deruxtecan as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens.

The approval was based on positive results from the single-arm DESTINY-Breast01 Phase II trial, in which Enhertu showed clinically meaningful and durable antitumour activity in patients with HER2-positive metastatic breast cancer who had received two or more prior anti-HER2-based regimens.

Enhertu is a HER2-directed antibody drug conjugate or ADC. It is the lead antibody drug conjugate in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca's ADC scientific platform.

Following EU approval, AstraZeneca will pay Daiichi Sankyo $75 million as a milestone payment for HER2-positive breast cancer.

Daiichi Sankyo and AstraZeneca entered a global collaboration to jointly develop and commercialise Enhertu in March 2019, and datopotamab deruxtecan in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of Enhertu and datopotamab deruxtecan.

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