LONSURF trifluridine and tipiracil

Drug Class

Nucleoside metabolic inhibitor and thymidine phosphorylase inhibitor

Mechanism

Trifluridine interferes with tumor DNA synthesis and cell proliferation, while tipiracil inhibits thymidine phosphorylase to prevent the degradation of trifluridine.

Approved Indication

Previously treated metastatic colorectal cancer, and previously treated metastatic gastric or gastroesophageal junction adenocarcinoma, per its FDA approval.

What This Means For Patients

Lonsurf is a combination chemotherapy tablet for patients with advanced metastatic colorectal cancer or gastric/GEJ cancer. It is designed to disrupt tumor cell DNA replication and can be accessed by international patients in the Hainan pilot zone.

Regulatory Approvals

• FDA — approved (2015) — label

Pivotal Clinical Evidence

• RECOURSE — Mayer et al., N Engl J Med 2015 (NCT01607957) — DOI

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lonsurf-metastatic-colorectal-cancer
• https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207981s000lbl.pdf