FDA approves Lonsurf for adults with metastatic gastric, gastroesophageal junction adenocarcinoma

The FDA approved trifluridine and tipiracil for the treatment of adults with metastatic gastric or gastroesophageal junction adenocarcinoma.

The approval applies to use of the agent for patients who received at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and — if appropriate — HER2-targeted therapy.

Trifluridine and tipiracil (Lonsurf, Taiho Oncology) is an oral agent that utilizes a dual mechanism of action to maintain clinical activity.

Trifluridine is an antineoplastic nucleoside analogue that interferes with DNA function. The blood concentration of trifluridine is maintained via tipiracil, an inhibitor of the FTD-degrading enzyme thymidine phosphorylase.

The approval is based on results of the randomized phase 3 TAGS trial, designed to compare the addition of trifluridine and tipiracil to best supportive care for patients with previously treated advanced gastric cancer or gastroesophageal junction adenocarcinoma who progressed after or were intolerant to standard therapy.

Results showed the agent extended OS compared with placebo, and its safety profile appeared consistent with that observed in prior studies.

“The approval of Lonsurf represents a significant milestone for patients living with advanced gastric or gastroesophageal junction adenocarcinoma who have limited effective treatment options after standard treatment options have failed,” Timothy Whitten, president and CEO of Taiho Oncology, said in a company-issued press release.

The FDA previously granted priority review designation to trifluridine and tipiracil.

The agent also is approved for patients with refractory metastatic colorectal cancer treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy; an anti-VEGF biological therapy; and, if RAS wild-type, an anti-EGFR therapy.