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: melphalan flufenamide
Trade Name: Pepaxto
Date Designated: 03/16/2015
Orphan Designation: Treatment of plasma cell myeloma, also referred to as multiple myeloma
Orphan Designation Status: Designated/Approved
Oncopeptides AB
Vastra Tradgardsgatan 15
Stockholm
Sweden

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

Marketing approved:

1 Generic Name: melphalan flufenamide
Trade Name: Pepaxto
Marketing Approval Date: 02/26/2021
Approved Labeled Indication: Treatment, in combination with dexamethasone, of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal antibody.
Exclusivity End Date: 02/26/2028 
Exclusivity Protected Indication* :  Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal antibody.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-