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AstraZeneca: FDA Grants Orphan Drug Designation To Enhertu For Gastric Cancer

AstraZeneca Plc (AZN.L,AZN) announced Friday that the U.S. Food and Drug Administration has granted Orphan Drug Designation or ODD to Enhertu (trastuzumab deruxtecan) in the US for the treatment of patients with gastric cancer, including gastroesophageal junction cancer.

AstraZeneca and Daiichi Sankyo Co., Ltd. jointly develop and commercialise Enhertu worldwide, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is solely responsible for manufacturing and supply.

FDA grants ODD to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. In the country, it is estimated that 27,600 new cases of gastric cancer will be diagnosed this year and the disease could lead to more than 11,000 deaths in 2020.

The Enhertu ODD follows recent US Breakthrough Therapy Designations for Enhertu for HER2-positive metastatic gastric cancer and HER2-mutant metastatic non-small cell lung cancer.

In the Phase II DESTINY-Gastric01 trial, patients with HER2-positive metastatic gastric or gastroesophageal cancer who were treated with Enhertu, a HER2-directed antibody drug conjugate, demonstrated a statistically significant and clinically meaningful improvement in objective response rate and overall survival.

The companies will present the full results of DESTINY-Gastric-01 during the 2020 American Society of Clinical Oncology ASCO20 Virtual Scientific Program, 29 to 31 May 2020.

Enhertu (5.4mg/kg) is approved in the US and Japan 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 based on the DESTINY-Breast01 trial.

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