Regorafenib for previously treated metastatic colorectal cancer

1.1 Regorafenib is recommended, within its marketing authorisation, as an option for metastatic colorectal cancer in adults who have had previous treatment (including fluoropyrimidine-based chemotherapy, anti‑VEGF therapy and anti‑EGFR therapy) or when these treatments are unsuitable. Regorafenib is only recommended if the company provides it according to the commercial arrangement.

Why the committee made these recommendations

The only treatment for metastatic colorectal cancer (mCRC) that has progressed after fluoropyrimidine-based chemotherapy, anti-vascular endothelial growth factor (anti-VEGF) therapy or anti-epidermal growth factor receptor (anti-EGFR) therapy, or when these are unsuitable, is trifluridine–tipiracil. When the cancer has progressed on trifluridine–tipiracil or it is not suitable, the only option is best supportive care. Regorafenib is another possible treatment option.

Clinical trial results show that regorafenib increases how long people live compared with best supportive care. There is no clinical trial evidence directly comparing regorafenib with trifluridine–tipiracil. An indirect treatment comparison suggests that regorafenib and trifluridine–tipiracil are likely to have similar clinical effectiveness.

The cost-effectiveness estimates are within what NICE considers an acceptable use of NHS resources. So, regorafenib is recommended.