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 Added Value
Évaluation des médicaments