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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 CD4+/CD8+ T cells expressing a BCMA-specific chimeric antigen receptor (CAR)
Date Designated: 09/28/2017
Orphan Designation: Treatment of Multiple Myeloma (MM)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Juno Therapeutics, Inc.
400 Dexter Avenue North
Suite 1200
Seattle, Washington 98109
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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