Reason for request

Re-assessment of the actual benefit

High clinical benefit for the treatment of advanced-stage clear cell kidney cancer or kidney cancer with a clear cell contingent after prior anti-VEGF therapy failure and moderate clinical added value compared to everolimus

  • OPDIVO has been granted a marketing authorisation for monotherapy treatment of adults suffering from advanced renal cell carcinoma after prior treatment.
  • Its superiority has been established over everolimus in terms of overall survival in patients with clear cell kidney cancer.
  • It is a second-line treatment after failure of prior tyrosine kinase treatment.

 


Clinical Benefit

Substantial

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Clinical Added Value

moderate

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Évaluation des médicaments