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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: autologous cell therapy product manufactured from tumor-infiltrating lymphocytes that have been harvested from surgically resected tumor tissue and expanded ex vivo
Date Designated: 11/28/2022
Orphan Designation: Treatment of stage IB2 (tumor size >2 cm) to stage IV cervical cancer
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 03/23/2023
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Instil Bio, Inc.
3963 Maple Avenue
Suite 350
Dallas, Texas 75219
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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