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FDA Grants Trastuzumab Deruxtecan Orphan Drug Status in Gastric Cancer

Gina Columbus @ginacolumbusonc
Published: Friday, May 22, 2020

The FDA has granted an orphan drug designation to fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of patients with gastric cancer, including gastroesophageal junction (GEJ) cancer.1

Orphan drug designation is designated for agents intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in United States. In the press release, Daiichi Sankyo noted that an estimated 27,600 new cases of gastric cancer will be diagnosed in 2020, and the disease could also lead to more than 11,000 deaths this year.


  1. Enhertu granted orphan drug designation in the U.S. for gastric cancer [news release]. Daiichi Sankyo Company; May 22, 2020. Accessed May 22, 2020.           
  2. Phase II DESTINY-Gastric01 trial of Enhertu versus chemotherapy met primary endpoint [news release]. AstraZeneca; January 27, 2020. Accessed January 27, 2020.
  3. Shitara K, Iwata H, Takahashi S, et al. Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive gastric cancer: a dose-expansion, phase 1 study. Lancet Oncol. 2019;20(6):827-836. doi10.1016/S1470-2045(19)30088-9

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