AstraZeneca, Daiichi Sankyo get Orphan Drug Designation for gastric cancer drug Enhertu
US: Daiichi Sankyo Company Limited and AstraZeneca's Enhertu (trastuzumab deruxtecan) has been granted Orphan Drug Designation (ODD) in the US for the treatment of patients with gastric cancer, including gastroesophageal junction cancer.
The Food and Drug Administration (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.
An estimated 27,600 new cases of gastric cancer will be diagnosed this year and the disease could lead to more than 11,000 deaths in the US in 2020.
In 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 (ADC), demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR), the primary endpoint, and overall survival (OS), a key secondary endpoint, versus patients treated with investigator's choice of chemotherapy (irinotecan or paclitaxel monotherapy).
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