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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: mobocertinib
Trade Name: Exkivity
Date Designated: 12/17/2019
Orphan Designation: Treatment of non-small cell lung cancer with genetic alterations in EGFR including EGFR mutations and/or EGFR gene amplifications, HER2 mutations, or BRAF G466V mutations
Orphan Designation Status: Designated/Approved
Takeda Development Center Americas, Inc.
500 Kendall Street
Cambridge, Massachusetts 02142
United States

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

Marketing approved:

1 Generic Name: mobocertinib
Trade Name: Exkivity
Marketing Approval Date: 09/15/2021
Approved Labeled Indication: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy (Indication withdrawn)
Exclusivity End Date: 07/15/2024 
Exclusivity Protected Indication* :  Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy (Indication withdrawn)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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