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AstraZeneca: FDA Grants Second Breakthrough Therapy Designation To Enhertu

AstraZeneca Plc (AZN.L,AZN) announced Monday that the U.S. Food and Drug Administration has granted Enhertu (trastuzumab deruxtecan) Breakthrough Therapy Designation or BTD in the US.

Enhertu, developed by AstraZeneca and Daiichi Sankyo Co., Ltd., was given the BTD for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.

Gastric cancer is the third leading cause of cancer mortality with a five-year survival rate of 5% for metastatic disease. Approximately one in five gastric cancers are considered HER2 positive.

The BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need.

The FDA granted BTD based on data from the registrational Phase II DESTINY-Gastric01 trial and data from the Phase I trial published in The Lancet Oncology.

This is the second BTD granted for Enhertu in the US. Enhertu received BTD in 2017 for HER2-positive metastatic breast cancer and received approval in December 2019.

The full results of DESTINY-Gastric-01 will be presented during the 2020 American Society of Clinical Oncology ASCO20 Virtual Scientific Program.

José Baselga, Executive Vice President, R&D Oncology, said, "Current therapy options are limited for patients with HER2-positive metastatic gastric cancer and for those who relapse, there are no approved HER2-targeted medicines. We look forward to working with the FDA to further explore the potential of Enhertu to become an important new treatment and the first antibody drug conjugate for this devastating disease."

Enhertu received SAKIGAKE designation in March 2018 by Japan's Ministry of Health, Labour and Welfare for potential use in the same HER2-positive gastric cancer patient population and was recently submitted to the MHLW for approval.

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