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STIVARGA (regorafenib), tyrosine kinase inhibitor
Reason for request
No clinical benefit demonstrated in the management of metastatic colorectal cancer
- STIVARGA has Marketing Authorisation in the treatment of adult patients with metastatic colorectal cancer 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.
- Compared with placebo, it slightly improves overall survival and is associated with substantial toxicity.
Clinical Benefit
| Low |
In the treatment of metastatic colorectal cancer previously treated with or not considered suitable for available therapies, in particular fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy, the actual benefit of STIVARGA : - is low for patients whose performance score is 0-1 |
| Insufficient |
- is insufficient for patients whose performance score is > 1 |
Clinical Added Value
| no clinical added value |
Given the safety profile and the poor level of effect, the Committee considers that STIVARGA does not provide any improvement in actual benefit (level V, non-existent) in the treatment of metastatic colorectal cancer patients who failed on or were not considered candidates for available therapies (fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy) and whose performance score is 0 or 1. |
