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# Lonsurf & Bevacizumab OK’d in Colon Cancer
- URL: https://www.fdaweb.com/lonsurf-bevacizumab-okd-in-colon-cancer/
- Published: 2023-08-02T12:00:00.000Z
- Updated: 2026-09-14T18:47:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155014

FDA has approved Taiho Oncology’s Lonsurf (trifluridine and tipiracil) with bevacizumab for treating metastatic colorectal cancer (mCRC) patients previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. In 2015, the agency approved single-agent Lonsurf for this indication.

The new approval was based on data from the SUNLIGHT (NCT04737187) trial involving 492 patients with mCRC who received a maximum of two prior chemotherapy regimens and demonstrated progressive disease or intolerance to the last regimen. Data demonstrated a statistically significant overall survival (OS) improvement in patients randomized to the Lonsurf plus bevacizumab arm compared to those randomized to Lonsurf, an [FDA release](https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-trifluridine-and-tipiracil-bevacizumab-previously-treated-metastatic-colorectal-cancer?ref=fdaweb.com) says. Median OS was 10.8 months in the Lonsurf plus bevacizumab arm and 7.5 months in the Lonsurf arm, it says.

The most common adverse reactions or laboratory abnormalities for Lonsurf with bevacizumab were neutropenia, anemia, thrombocytopenia, fatigue, nausea, increased AST, increased ALT, increased alkaline phosphatase, decreased sodium, diarrhea, abdominal pain, and decreased appetite, the agency says.