Nordic B V — Teysuno EMA EPAR variation assessment report (EMEA/H/C/001242, 2011)

Report summary

This report summarizes the assessment of a Type II variation for Teysuno (tegafur/gimeracil/oteracil) to extend its indication for metastatic colorectal cancer (mCRC). The proposed use is as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for mCRC patients unable to continue other fluoropyrimidine treatments due to hand-foot syndrome or cardiovascular toxicity. Clinical trials and meta-analyses, including the SALTO trial and studies comparing S-1 based regimens (SOX, IRIS) to 5FU/Capecitabine-based therapies (CapeOX, mFOLFOX6, FOLFIRI), demonstrated non-inferiority in progression-free survival (PFS) and overall survival (OS). Efficacy and safety data, including adverse events like HFS, neutropenia, and diarrhea, were evaluated across various S-1 combinations and patient populations, including European and Asian cohorts. Retrospective analyses supported the benefit of switching to S-1 due to toxicity. The assessment concluded a positive benefit-risk balance for the proposed indication.

Key findings — cited to the page