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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ciltacabtagene autoleucel
Trade Name: Carvykti
Date Designated: 02/01/2019
Orphan Designation: Treatment of multiple myeloma (MM)
Orphan Designation Status: Designated/Approved
Janssen Research & Development, LLC
920 US Highway 202
Raritan, New Jersey 08869
United States

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

Marketing approved:

1 Generic Name: ciltacabtagene autoleucel
Trade Name: Carvykti
Marketing Approval Date: 02/28/2022
Approved Labeled Indication: Treatment of adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
Exclusivity End Date: 02/28/2029 
Exclusivity Protected Indication* :  Treatment of adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
2 Generic Name: ciltacabtagene autoleucel
Trade Name: Carvykti
Marketing Approval Date: 04/05/2024
Approved Labeled Indication: treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide
Exclusivity End Date: 04/05/2031 
Exclusivity Protected Indication* :  treatment of adult patients with relapsed or refractory multiple myeloma, who have received 1, 2, or 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide, or who have received 4 or more prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, but not including an anti-CD38 monoclonal antibody, and are refractory to lenalidomide
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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