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Lonsurf FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 7, 2023.

FDA Approved: Yes (First approved September 22, 2015)
Brand name: Lonsurf
Generic name: tipiracil hydrochloride and trifluridine
Dosage form: Tablets
Company: Taiho Oncology, Inc.
Treatment for: Colorectal Cancer, Gastric Cancer

Lonsurf (tipiracil hydrochloride and trifluridine) is a thymidine phosphorylase inhibitor and nucleoside metabolic inhibitor combination used for the treatment of colorectal cancer and gastric or gastroesophageal junction adenocarcinoma.

  • Lonsurf is indicated for the treatment of adult patients with:
    - metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an antiEGFR therapy.
    - 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.
  • Lonsurf contains two ingredients that work together to treat cancer. Following uptake into cancer cells, trifluridine is incorporated into the DNA, interfering with DNA synthesis and inhibiting cell proliferation. Tipiracil increases trifluridine exposure by inhibiting its metabolism by thymidine phosphorylase.
  • Lonsurf tablets are administered orally twice daily with food on Days 1 through 5 and Days 8 through 12 of each 28-day cycle.
  • Warnings and precautions associated with Lonsurf include severe myelosuppression and embryo-fetal toxicity.
  • Common adverse reactions for Lonsurf when used as a single agent include neutropenia, anemia, thrombocytopenia, fatigue, nausea, decreased appetite, diarrhea, vomiting, abdominal pain, and pyrexia.
    Common adverse reactions when used in combination with bevacizumab include neutropenia, anemia, thrombocytopenia, fatigue, nausea, increased AST, increased ALT, increased alkaline phosphatase, decreased sodium, diarrhea, abdominal pain, and decreased appetite.

Development timeline for Lonsurf

Aug  2, 2023Approval FDA Approves Lonsurf (trifluridine/tipiracil) in Combination With Bevacizumab for Adult Patients With Metastatic Colorectal Cancer (mCRC)
Feb 25, 2019Approval FDA Approves Lonsurf (trifluridine/tipiracil) for Adult Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Sep 22, 2015Approval FDA Approves Lonsurf (tipiracil and trifluridine) for Advanced Colorectal Cancer
Feb 23, 2015Taiho Oncology, Inc. Announces TAS-102 NDA for Refractory Metastatic Colorectal Cancer Accepted for Review by FDA

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.