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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: sevabertinib
Trade Name: Hyrnuo
Date Designated: 03/11/2025
Orphan Designation: treatment of non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations, and/or human epidermal growth factor receptor 2 (HER2) activating mutations
Orphan Designation Status: Designated/Approved
Bayer HealthCare Pharmaceuticals Inc.
238 Main Street, 11th Floor
Cambridge, New Jersey 02142
United States

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

Marketing approved:

1 Generic Name: sevabertinib
Trade Name: Hyrnuo
Marketing Approval Date: 11/19/2025
Approved Labeled Indication: treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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