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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: loncastuximab tesirine-lpyl
Trade Name: Zynlonta
Date Designated: 06/08/2017
Orphan Designation: Treatment of diffuse large B-cell lymphoma
Orphan Designation Status: Designated/Approved
ADC Therapeutics SA
Route de la Corniche, 3B
Epalinges, Vaud
Switzerland

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

Marketing approved:

1 Generic Name: loncastuximab tesirine-lpyl
Trade Name: Zynlonta
Marketing Approval Date: 04/23/2021
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, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma
Exclusivity End Date: 04/23/2028 
Exclusivity Protected Indication* :  treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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