Reason for request

Extension d'indication

High clinical benefit for urothelial cancer and minor clinical added value compared to chemotherapy in terms of overall survival.  

 

  • KEYTRUDA has been granted a marketing authorisation for the monotherapy treatment of adults with locally advanced or metastatic urothelial cancer having received prior platinum salt-based chemotherapy.

  • Its superiority over chemotherapy has been established: absolute gain in median overall survival of 2.9 months in favour of pembrolizumab.

  • It is the preferred therapeutic option over chemotherapy for second- and third-line treatments for these patients. However, KEYTRUDA increases the risk of death in the first two months of treatment compared to chemotherapy.

 

 

 


Clinical Benefit

Substantial

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Clinical Added Value

minor

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