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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: avutometinib; defactinib
Trade Name: Avmapki Fakzynja Co-Pack
Date Designated: 03/05/2024
Orphan Designation: Treatment of low grade serous ovarian cancer (LGSOC)
Orphan Designation Status: Designated/Approved
Verastem, Inc.
117 Kendrick Street
Suite 500
Needham, Massachusetts 02494
United States

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

Marketing approved:

1 Generic Name: avutometinib; defactinib
Trade Name: Avmapki Fakzynja Co-Pack
Marketing Approval Date: 05/08/2025
Approved Labeled Indication: treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy
Exclusivity End Date: 05/08/2032 
Exclusivity Protected Indication* :  treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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