FOTIVDA (tivozanib), protein kinase inhibitor
ONCOLOGY - New medicinal product
Opinions on drugs -
Posted on
Feb 06 2019
Reason for request
Inclusion
Insufficient clinical benefit to justify reimbursement for the treatment of metastatic renal cancer
FOTIVDA has been granted a marketing authorisation for the first-line treatment of adults suffering from advanced stage renal cell carcinoma (RCC) and in patients who have never received VEGFR and mTOR pathway inhibitors, following disease progression after previous cytokine treatment for advanced stage RCC.
The available data do not allow the impact in terms of morbidity and mortality to be quantified due to the profile of the patients included (70% in first-line) and of the comparator, unsuitable for first-line, selected in the study.
Clinical Benefit
Insufficient |
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Clinical Added Value
Not applicable |
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