• 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: trifluridine/tipiracil
Trade Name: LONSURF
Date Designated: 04/17/2017
Orphan Designation: Treatment of gastric cancer including cancer of the gastroesophageal junction
Orphan Designation Status: Designated/Approved
Taiho Oncology, Inc.
101 Carnegie Center
Suite 101
Princeton, New Jersey 08540
United States

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

Marketing approved:

1 Generic Name: trifluridine/tipiracil
Trade Name: LONSURF
Marketing Approval Date: 02/22/2019
Approved Labeled Indication: LONSURF is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
Exclusivity End Date: 02/22/2026 
Exclusivity Protected Indication* :  LONSURF is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

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