Therapy Areas: Cardiovascular
AstraZeneca and Daiichi Sankyo report trastuzumab deruxtecan granted US FDA Priority Review
18 October 2019 -

AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, and global pharmaceutical company Daiichi Sankyo Company Limited (TYO:4568) announced on Thursday that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for trastuzumab deruxtecan (DS-8201) and granted Priority Review.

The Prescription Drug User Fee Act (PDUFA) date for the HER2-targeting antibody drug conjugate (ADC) and potential new medicine for the treatment of HER2-positive metastatic breast cancer is set for the second quarter of 2020.

Reportedly, this Priority Review draws on the strength and the consistency of results seen in the phase I and phase II trials and is a critical step on the journey to deliver this potential new medicine to patients.

Trastuzumab deruxtecan was previously granted US FDA Breakthrough Therapy Designation and Fast Track designation. This BLA is based on the combination of data from the phase I trial published in The Lancet Oncology and the pivotal phase II DESTINY-Breast01 trial.

Also, detailed data from DESTINY-Breast01 will be presented at the forthcoming San Antonio Breast Cancer Symposium in December 2019.

In March 2019 AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise trastuzumab deruxtecan as a potential new medicine worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply in Japan.

AstraZeneca focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology; Cardiovascular, Renal and Metabolism (CVRM); and Respiratory.



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