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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: bispecific T-cell engager antibody consisting of 2 single chain variable fragment binding domains specific for antigen Delta-like protein 3 (DLL3) and for TCR-associated complex CD3
Date Designated: 12/27/2018
Orphan Designation: Treatment of small cell lung cancer (SCLC)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Amgen Inc.
1 Amgen Center Drive
Mail Stop 27-2-D
Thousand Oaks, California 91320
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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