Approval for Lonsurf
September 22, 2015 – The U.S. Food and Drug Administration (FDA) approved Lonsurf (trifluridine and tipiracil) for the treatment of patients with metastatic colorectal cancer who are no longer responding to other therapies such as fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF biological therapy, and anti-EGFR therapy if RAS wild-type. Colorectal cancer is the third most common non-skin cancer in the U.S. among men and women.
Manufactured by Taiho Oncology Inc., Lonsurf is an oral tablet combining two drugs, trifluridine and tipiracil. Trifluridine is an antineoplastic nucleoside metabolic inhibitor that interferes with the function of DNA in cells and Tipiracil works by inhibiting the enzyme that degrades trifluridine, thymidine phosphorylase, thereby increasing blood levels of trifluridine. The FDA’s approval of Lonsurf was based on a clinical trial that showed patients treated with Lonsurf lived an average of 7.1 months compared to 5.3 months for those treated with placebo. The average time to disease progression for patients on Lonsurf was two months compared to 1.7 months for patients receiving placebo. The use of Lonsurf can cause severe decrease in cells that provide immunity, carry oxygen, and help with blood clotting (myelosuppression) and may cause fetal harm. The FDA recommends obtaining of complete blood counts prior to starting each treatment cycle of Lonsurf. The FDA further recommends that blood counts should be monitored throughout treatment, and women should be advised of the potential risks to fetal development and should not breastfeed while taking Lonsurf. The recommended dosing for Lonsurf is 35mg/m2 orally twice daily on days 1 through 5 and days 8 through 12 of each 28-day cycle. Lonsurf is expected to be launched on October 6, 2015.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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