AFINITOR (everolimus) - Neuroendocrine tumours of pancreatic origin

The Committee deems that the clinical benefit of AFINITOR (everolimus) 5 and 10 mg remains substantial in the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.

Considering:

• the significant methodological limitations of the OPALINE post-registration study, which does not enable the efficacy of everolimus (AFINITOR) in terms of progression-free
  survival to be compared with that of sunitinib or of the other alternatives; this study does not therefore meet the expectations of the Committee,
• the absence of an expected additional benefit on overall survival compared to these alternatives,
• the absence of quality of life data,
• the poor safety profile of everolimus,

the Committee now deems that AFINITOR (everolimus) provides no clinical added value (CAV V) in the care pathway of adult patients with unresectable or metastatic, well- or
moderately-differentiated neuroendocrine tumours of pancreatic origin.