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STIVARGA (regorafenib), protein kinase inhibitor

ONCOLOGY - New indication
Opinions on drugs - Posted on Apr 18 2016

Reason for request

Extension of inclusion

Minor improvement in the third-line treatment of unresectable or metastatic gastrointestinal stromal tumours

  

  • STIVARGA now has Marketing Authorisation in the treatment of unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib.
  • Its efficacy compared with placebo has been demonstrated in terms of progression-free survival in patients with an ECOG score of 0 or 1, at the cost of toxicity. The data do not allow the improvement in overall survival to be assessed.

 


Clinical Benefit

Substantial

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Clinical Added Value

minor

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