Teysuno

Teysuno is approved for advanced gastric cancer since 2011. It received orphan medicinal product designation on 20 December 2007 for gastric cancer, with a prevalence of 3 per 10,000 EU populations. This designation was withdrawn on 12 January 2011. Marketing Authorisation for Teysuno was granted in Japan on 25 January 1999, in South Korea on 29 July 2003, and in China on 9 January 2009. A Type II variation application was submitted on 13 October 2020.

In studies comparing S-1 to 5FU/Capecitabine in metastatic colorectal cancer (mCRC), the PFS HR was 0.95, with a 99% CI upper limit of 1.08. For first-line mCRC, the PFS HR was 0.92, and for second-line mCRC, it was 1.06. The OS HR for S-1 vs 5FU/Capecitabine in mCRC was 0.93, with 0.94 for first-line and 0.90 for second-line mCRC. Median overall survival in the total population was 12 months, increasing to 15 months in patients who received systemic therapy. The 5-year survival rate was 60%, with a median overall survival of 30 months.

Safety findings indicate that hand-foot syndrome frequency with capecitabine ranged from 22-63%, diarrhoea at 50%, and cardiotoxicity at 1.2%-5.9%. Switching to S-1 resulted in a 94% reduction in HFS severity and complete resolution of HFS-related symptoms in 56% of cases. Treatment discontinuations due to S-1 related adverse events were 7.6%.