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Taiho Oncology and Taiho Pharmaceutical gain FDA approval for Lonsurf
2023-08-03
上市批准临床结果临床3期
Lonsurf has been approved to treat adult patients with metastatic colorectal cancer. Credit: crystal light / Shutterstock.com.
Lonsurfncology and Taiho Pharmaceutical have received ametastatic colorectal cancer Drug Administration (FDA) for Lonsurf to treat adult patients with metastatic colorectal cancer (mCRC).
Taiho Oncologys intTaiho Pharmaceuticalurf either as a single agent or withFood and Drug Administration (FDA)y treLonsurfth oxaliplatin, fluoropyrimidimetastatic colorectal cancer (mCRC)y, an anti-VEGF biological therapy, and if RAS wild-type [without mutations], with an anti-EGFR therapy.
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Taiho Pharmaceutical discovered and developed Lonsurf, an oral nucleoside antitumour agent.
It contains trifluridine, a nucleoside analogue based on thymidine, along with tipiracil, an inhibitor of thymidine phosphorylase (TP). This combination enhances exposure to trifluridine by inhibiting its metabolism by TP.
Based on data from the Phase III SUNLIGHT study, the FDA granted approval for the combination of Lonsurf and bevacizumab.
Taiho Pharmaceuticalwed improvements in progreLonsurfree survival and overall survival in patients with mCRC after disease progression or who could not tolerate two previous chemotherapy regimens.
These resulttrifluridinered to the outcomes using LONSURF alone.tipiraciltrifluridine
Taiho Oncology president and CEO Timothy Whitten statFDA “The treatment of advanced colorectal caLonsurfs beebevacizumabcus of our work at Taiho Oncology since our inception and with good reason: approximately 22% of patients with colorectal cancer in the US are diagnosed after the cancer has metastasised.
“The FDA approval of Lonsurf in combination with bevacizumab is another example of how we are continuingmCRCadvance care in this disease and provide new hope to patients and their families.”
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