4.1 Therapeutic indications
CAMPTO is indicated for the treatment of patients with advanced colorectal cancer:
• in combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for advanced disease,
• as a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen.
CAMPTO in combination with cetuximab is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing RAS wild-type metastatic colorectal cancer, who had not received prior treatment for metastatic disease or after failure of irinotecan-including cytotoxic therapy (see section 5.1).
CAMPTO in combination with 5-fluorouracil, folinic acid and bevacizumab is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum.
CAMPTO in combination with capecitabine with or without bevacizumab is indicated for first-line treatment of patients with metastatic colorectal carcinoma.
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Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).