New Medicines

Teysuno Metastatic colorectal cancer


Licence extension / variation

Development and Regulatory status

Feb 22Approved in the EU [5].
Oct 21Recommended for EU approval by CHMP – the extension to the existing indication is “for use as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting” [1].


Teysuno is a combination of three agents: tegafur (converted in vivo to 5-FU; gimeracil (which decreases the degradation of 5-FU by the body); and oteracil which decreases 5-FU activation in the GI tract.
Bowel cancer is the fourth most common cancer in the UK, accounting for 11% of all new cancer cases. Incidence rates are highest in people aged 85 to 89 [2].
Metastatic colorectal cancer

Trial or other data

Dec 21Previously in Mar 14, Taiho completed the PIII SOFT trial, which investigated non-inferiority of S 1 + oxaliplatin + bevacizumab compared with standard regimen fluorouracil + folinic acid + oxaliplatin (mFOLFOX6) + bevacizumab in patients with metastatic colorectal cancer (JapicCTI090699). The primary end-point was to assess progression free survival [3].
Mar 18PIII SALTO trial completes (NCT01918852). It met the primary end point with a lower incidence of hand-foot syndrome (HFS) in patients who were administered S 1. Nordic Pharma and Dutch Colorectal Cancer Group completed the trial, that evaluated the safety of S 1 versus capecitabine in the first-line treatment of patients with metastatic colorectal cancer. The randomised, parallel-assignment, open-label study was initiated in December 2013, and enrolled 161 patients in the Netherlands [3,4].
Jun 12PIII TRICOLORE trial to evaluate the efficacy and tolerability of S 1 in combination with irinotecan and bevacizumab, compared with oxaliplatin-based chemotherapy (mFOLFOX6), as first-line therapy in patients with colorectal cancer starts (UMIN000007834). The randomised, open-label trial will enrol 487 patients in Japan [3].

Evidence based evaluations