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Taiho Pharmaceutical and Taiho Oncology Receive Approval for LONSURF®

Friday, August 04, 2023

Taiho Pharmaceutical and Taiho Oncology have received approval from the U.S. Food and Drug Administration (FDA) for the use of LONSURF® (trifluridine/tipiracil) in the treatment of metastatic colourectal cancer (mCRC) among adult patients.

This approval covers the usage of LONSURF as a standalone treatment or in combination with bevacizumab. The eligible patient group includes those with previously undergone fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, along with anti-VEGF biological therapy. Additionally, if the patients have RAS wild-type, they can also receive an antiEGFR therapy.

The authorisation of this combination therapy marks a significant advancement in the treatment options for individuals with mCRC, and has shown the ability to extend patients' lives in comparison to the usage of LONSURF alone.

LONSURF is categorized as an oral nucleoside antitumor agent. Its composition includes trifluridine, a thymidine-based nucleoside analog, as well as tipiracil, a thymidine phosphorylase (TP) inhibitor. This combination is designed to boost trifluridine levels by curtailing its breakdown through TP inhibition. Trifluridine plays a role in the disruption of DNA function and the inhibition of cell proliferation by integrating into DNA.

The outcome of the Phase 3 SUNLIGHT trial has showcased the efficacy of the LONSURF and bevacizumab combination. This treatment approach has exhibited statistically significant and clinically substantial enhancements in both overall survival (OS) and progression-free survival (PFS) for patients with mCRC.

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