The FDA approves Lonsurf plus bevacizumab for metastatic colorectal cancer

August 2023

The US Food and Drug Administration (FDA) has approved the combination therapy of trifluridine/tipiracil (Lonsurf) and bevacizumab for the treatment of adults with metastatic colorectal cancer (mCRC) who have received previous treatment with 5-FU-, oxaliplatin- and irinotecan-based chemotherapy (such as FOLFOX and FOLFIRI), an anti-VEGF targeted therapy (such as bevacizumab), and if they are RAS wild-type, an anti-EGFR therapy such as panitumumab or cetuximab. Lonsurf is approved as a single agent treatment for patients with previously treated mCRC.

The FDA approval is based on findings from the phase III SUNLIGHT trial. This trial compared Lonsurf plus bevacizumab to Lonsurf alone for patients with mCRC who received a maximum of 2 previous lines of chemotherapy and experienced disease progression or resistance to treatment (i.e. treatment stopped working). Median progression-free survival was 5.6 months compared to 2.4 months in the combination and Lonsurf alone arm, respectively. Median overall survival was 10.8 months compared to 7.5 months in in the combination and Lonsurf alone arm, respectively.

In Canada, Lonsurf is approved by Health Canada for the treatment of refractory mCRC. It is currently only reimbursed in the province of Quebec. Lonsurf in combination with bevacizumab is currently only available through clinical trials.