Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links

Search Orphan Drug Designations and Approvals

-

Marketing approved:
Generic Name:	idecabtagene vicleucel
Trade Name:	Abecma
Date Designated:	05/11/2016
Orphan Designation:	Treatment of multiple myeloma
Orphan Designation Status:	Designated/Approved
Sponsor:	Celgene Corporation, a Bristol-Myers Squibb Company 86 Morris Avenue Summit, New Jersey 07901 United States The sponsor address listed is the last reported by the sponsor to OOPD.

1	Generic Name:	idecabtagene vicleucel
	Trade Name:	Abecma
	Marketing Approval Date:	03/26/2021
	Approved Labeled Indication:	treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody
	Exclusivity End Date:	03/26/2028
	Exclusivity Protected Indication* :	treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody

2	Generic Name:	idecabtagene vicleucel
	Trade Name:	Abecma
	Marketing Approval Date:	04/04/2024
	Approved Labeled Indication:	treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody
	Exclusivity End Date:	04/04/2031
	Exclusivity Protected Indication* :	treatment of adult patients with relapsed or refractory multiple myeloma after two or three prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.

-

-