Taiho Oncology and Taiho Pharmaceutical have received approval from the US Food and Drug Administration (FDA) for Lonsurf to treat adult patients with metastatic colorectal cancer (mCRC).

The approval is intended for using Lonsurf either as a single agent or with bevacizumab in patients previously treated with oxaliplatin, fluoropyrimidine and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type [without mutations], with an anti-EGFR therapy.

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.

This combination showed improvements in progression-free survival and overall survival in patients with mCRC after disease progression or who could not tolerate two previous chemotherapy regimens.

These results were compared to the outcomes using LONSURF alone.

Taiho Oncology president and CEO Timothy Whitten stated: “The treatment of advanced colorectal cancer has been a core focus 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 continuing to advance care in this disease and provide new hope to patients and their families.”