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STIVARGA (regorafenib), tyrosine kinase inhibitor

ONCOLOGY - New medicinal product
Opinions on drugs - Posted on Mar 23 2015

Reason for request

Inclusion

 No clinical benefit demonstrated in the management of metastatic colorectal cancer

Actual benefit low in patients with an ECOG performance score equal to 0 or 1

 

  • 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.