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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  lisocabtagene maraleucel
Date Designated:  04/01/2020
Orphan Designation:  Treatment of mantle cell lymphoma
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Juno Therapeutics, Inc.
400 Dexter Avenue N
400 Dexter Avenue N
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 Jan. 1, 2013, to the present.