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FDA grants priority review to Lonsurf for advanced gastric adenocarcinoma
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The FDA granted priority review to a supplemental new drug application that seeks approval of trifluridine and tipiracil for previously treated advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, according to the agent’s manufacturer.
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 drug is approved for refractory metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy; an anti-VEGF biological therapy; and, if RAS wild-type, an anti-EGFR therapy.
The priority review designation for the supplemental application is based on results from the randomized phase 3 TAGS trial, which evaluated the agent versus placebo for patients with heavily pretreated metastatic gastric cancer who progressed on or were intolerant to prior therapies.
The global, double-blind trial — which included 507 adults who had received at least two prior regimens for advanced disease — met its primary endpoint of extended OS, as well as its secondary endpoint of prolonged PFS.
The FDA is scheduled to make a decision on the application by Feb. 24.