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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tepotinib
Trade Name: Tepmetko
Date Designated: 10/26/2020
Orphan Designation: Treatment of non-small cell lung cancer with MET genomic tumor aberrations
Orphan Designation Status: Designated/Approved
EMD Serono, Inc.
One Technology Place
Rockland, Massachusetts 02370
United States

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

Marketing approved:

1 Generic Name: tepotinib
Trade Name: Tepmetko
Marketing Approval Date: 02/03/2021
Approved Labeled Indication: treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations
Exclusivity End Date: 02/03/2028 
Exclusivity Protected Indication* :  treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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