Search Orphan Drug Designations and Approvals

Marketing approved:
Generic Name:	selpercatinib
Trade Name:	Retevmo
Date Designated:	05/19/2022
Orphan Designation:	Treatment of tissue-agnostic RET fusion-positive solid tumors
Orphan Designation Status:	Designated/Approved
Sponsor:	Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285 United States The sponsor address listed is the last reported by the sponsor to OOPD.

1	Generic Name:	selpercatinib
	Trade Name:	Retevmo
	Marketing Approval Date:	09/21/2022
	Approved Labeled Indication:	Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options
	Exclusivity End Date:	09/21/2029
	Exclusivity Protected Indication* :	Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.