TEYSUNO (tegafur/gimeracil/oteracil) - Colorectal cancer

New indication.

Key points

Unfavourable opinion on reimbursement in the new indication of the MA: “Teysuno is indicated in adults 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”.

Role in the care pathway?

Taking account of the following elements:

• the suggestion of non-inferiority in terms of efficacy compared to 5-FU or capecitabine-based chemotherapy with regard to progression-free survival,
• the superiority in terms of tolerance of TEYSUNO (tegafur, gimeracil, oteracil) in monotherapy compared to capecitabine with regard to the incidence of hand-foot syndrome,
• the suggestion of a reduction in cardiotoxicity and hand-foot syndrome after a change of treatment in patients who cannot continue treatment with fluoropyrimidines,
• an increase in some gastrointestinal and renal adverse events compared to capecitabine,

and of the absence of: 

• comparison of the incidence of hand-foot syndrome versus 5-FU, used in clinical practice and resulting in less hand-foot syndrome than capecitabine,
• data versus TOMUDEX (raltitrexed), a clinically relevant comparator for this line of treatment,

the Committee considers that TEYSUNO 15 mg/4.35 mg/11.8 mg and TEYSUNO 20 mg/5.8 mg/15.8 mg (tegafur, gimeracil, oteracil), capsule, has no role in the therapeutic management strategy for patients with metastatic colorectal cancer in whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity arising in the adjuvant or metastatic setting.