AFINITOR (everolimus), tyrosine kinase inhibitor
ONCOLOGY - New indication
Opinions on drugs -
Posted on
Jun 25 2018
Reason for request
Extension of indication
High clinical benefit but no proven clinical added value for the current treatment of progressive, non-functional, well-differentiated, non-resectable or metastatic gastrointestinal neuroendocrine tumours in adults
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AFINITOR has been granted a marketing authorisation for the treatment of progressive, non-functional, well-differentiated (Grade 1 or 2), non-resectable or metastatic gastrointestinal or pulmonary neuroendocrine tumours (NETs) in adults.
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A gain in progression-free survival versus placebo has been demonstrated, though there is no proven benefit in terms of overall survival or quality of life.
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Treatment discontinuation due to adverse events has been observed in almost one third of patients.
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No data versus recommended therapeutic alternatives are available for certain clinical gastrointestinal NET scenarios.
Clinical Benefit
Substantial |
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Clinical Added Value
no clinical added value |
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