Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: fully humanized anti-CDH17 IgG1 monoclonal antibody conjugated to the microtubule-disrupting cytotoxic payload monomethyl auristatin E via a protease-cleavable linker [MC-VC-PAB-MMAE]
Date Designated: 12/13/2025
Orphan Designation: treatment of pancreatic cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Arbele Corporation
12011 NE BEL-RED ROAD
#201
BELLEVUE, Washington 98005
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-