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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

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Clinical Added Value

no clinical added value

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