EU approves Lonsurf for gastric cancer.- Servier and Taiho Pharma

Servier and Taiho Pharmaceutical announced that the European Commission (EC) has approved the use of Lonsurf (trifluridine/tipiracil) as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

The marketing authorization was supported by data from the global Phase III trial TAGS (TAS-102 Gastric Study) which was a randomized, double-blind study evaluating Lonsurf plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer refractory to standard treatments. Lonsurf demonstrated statistically significant improvement in overall survival (OS) (HR=0.69 [95% CI 0.56-0.85], p=0.00029) compared to placebo plus BSC. The median OS in patients treated with Lonsurf and BSC was 5.7 months compared to 3.6 months in patients treated with placebo and BSC, and there was a 31% risk reduction of death. The overall safety profile was consistent with the known safety profile of Lonsurf in metastatic colorectal cancer (CRC), with mainly hematological adverse events reported.