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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: axicabtagene ciloleucel
Trade Name: Yescarta
Date Designated: 04/25/2016
Orphan Designation: Treatment of follicular lymphoma.
Orphan Designation Status: Designated/Approved
Kite Pharma, Inc.
2400 Broadway
Santa Monica, California 90404
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: axicabtagene ciloleucel
Trade Name: Yescarta
Marketing Approval Date: 10/18/2017
Approved Labeled Indication: Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma
Exclusivity End Date: 10/18/2024 
Exclusivity Protected Indication* :  Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, treatment of adult patients with relapsed or refractory DLBCL arising from follicular lymphoma after two or more lines of systemic therapy, and treatment of adult patients with relapsed or refractory primary mediastinal B-cell lymphoma after two or more lines of systemic therapy (not including treatment of patients with primary central nervous system lymphoma)
2 Generic Name: axicabtagene ciloleucel
Trade Name: Yescarta
Marketing Approval Date: 03/05/2021
Approved Labeled Indication: Treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
Exclusivity End Date: 03/05/2028 
Exclusivity Protected Indication* :  Treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy, excluding patients with diffuse large B-cell lymphoma arising from follicular lymphoma.
3 Generic Name: axicabtagene ciloleucel
Trade Name: Yescarta
Marketing Approval Date: 04/01/2022
Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.
Exclusivity End Date: 04/01/2029 
Exclusivity Protected Indication* :  treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, treatment of adult patients with DLBCL arising from follicular lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, and treatment of adult patients with primary mediastinal B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy (not including treatment of patients with primary central nervous system lymphoma and excluding patients covered by the indication that received marketing approval on October 18, 2017 for Yescarta)
*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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