In February 2019, the FDA approved Lonsurf (trifluridine plus tipiracil; from Taiho Pharmaceuticals), an oral pill that combines 2 types of drugs, for the treatment of patients with metastatic (spreading) gastric (stomach) cancer or gastroesophageal junction adenocarcinoma after receiving at least 2 different chemotherapy regimens. Lonsurf was previously approved for metastatic colorectal cancer.
The FDA approved this new use of Lonsurf based on the results of a clinical trial that included 507 patients with metastatic gastric cancer or gastroesophageal junction adenocarcinoma. Patients received either Lonsurf and best supportive care or placebo and best supportive care. The average duration of survival was almost twice as long among patients who received Lonsurf than those who received placebo: 5.7 months with Lonsurf versus only 3.6 months with placebo. The time without disease progression was also much longer with Lonsurf than with placebo.
The most common side effects with Lonsurf in this study were risk of infection (neutropenia), anemia, diarrhea, decreased appetite, nausea, low levels of platelets (thrombocytopenia), and vomiting.
