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
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.
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.
Treatment discontinuation due to adverse events has been observed in almost one third of patients.
No data versus recommended therapeutic alternatives are available for certain clinical gastrointestinal NET scenarios.
Clinical Benefit
Substantial |
- |
Clinical Added Value
no clinical added value |
- |
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