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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: rondecabtagene autoleucel
Date Designated: 01/26/2026
Orphan Designation: treatment of diffuse large B-cell lymphoma (DLBCL)/high grade B-cell lymphoma (HGBCL) with MYC and BCL2 rearrangements
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Lyell Immunopharma, Inc.
201 Haskins Way
South San Francisco, California 94080
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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