mCRC Guidelines

Use Stivarga

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(regorafenib) as part of an individualised treatment plan for eligible patients with mCRC to improve outcomes by using all available treatments

Stivarga is indicated as monotherapy for the treatment of adult patients with:

• Metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy
• Unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on, or are intolerant to, prior treatment with imatinib and sunitinib
• Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib

The decision to recommend Stivarga was based on a need for more treatment options for mCRC patients who have progressed after fluoropyrimidine-based chemotherapy, anti-VEGF therapy or anti-EGFR therapy, or when these are unsuitable. Until now, only one other option (trifluridine-tipiracil) has been available to these patients on the NHS, and following this, only best supportive care was available.

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

The cost-effectiveness estimates for Stivarga are within what NICE and SMC consider an acceptable use of NHS resources.

Additionally, Stivarga is also reimbursed under NICE guidance for HCC and NICE guidance for GIST

Abbreviations: EGFR: epidermal growth factor receptor; ESMO: European Society for Medical Oncology; GIST: gastrointestinal stromal tumour; HCC: hepatocellular carcinoma; mCRC: metastatic colorectal cancer; NCCN: National Comprehensive Cancer Network; NICE: National Institute for Health and Care Excellence; VEGF: vascular endothelial growth factor.