Search Orphan Drug Designations and Approvals
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Generic Name: | half-life extended bispecific T cell engager (BiTE®) antibody construct designed to target both CLDN18.2 and CD3 |
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Date Designated: | 07/31/2020 |
Orphan Designation: | Treatment of gastric cancer, including cancer of gastroesophageal junction |
Orphan Designation Status: | Designated |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Amgen, Inc. One Amgen Center Drive Thousand Oaks, California 91320 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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