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AstraZeneca: FDA Grants Priority Review For Trastuzumab Deruxtecan

British drug maker AstraZeneca Plc (AZN.L,AZN) and Japan's Daiichi Sankyo Company, Limited announced that the US Food and Drug Administration has granted Trastuzumab deruxtecan priority review for the treatment of patients with HER2-positive metastatic breast cancer.

The FDA accepted for review the Biologics License Application or BLA for trastuzumab deruxtecan (DS-8201), a HER2-targeting antibody drug conjugate or ADC.

The companies noted that the Prescription Drug User Fee Act or PDUFA date for trastuzumab deruxtecan is set for the second quarter of 2020.

José Baselga, Executive Vice President, Oncology R&D, said, "Trastuzumab deruxtecan has the potential to transform the treatment landscape for patients with HER2-positive metastatic breast cancer who have limited treatment options today. 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."

Antoine Yver, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo, added that following the recent regulatory submission in Japan, the company looks forward to working closely with regulatory authorities to bring trastuzumab deruxtecan to patients in the US and Japan as soon as possible.

Trastuzumab deruxtecan was previously granted US FDA Breakthrough Therapy Designation and Fast Track designation.

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

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