Reason for request

Extension of indication

Moderate clinical benefit in combination with FOLFIRI chemotherapy (irinotecan, folinic acid and 5-fluorouracil) in the treatment of metastatic colorectal cancer.

  

  • CYRAMZA has Marketing Authorisation in combination with FOLFIRI chemotherapy (irinotecan, folinic acid and 5-fluorouracil) in the treatment of metastatic colorectal cancer (mCRC) in which the illness progressed during or after treatment with bevacizumab, oxaliplatin and a fluoropyrimidine.
  • A modest effect of CYRAMZA on overall survival and progression-free survival has been demonstrated versus placebo, but no improvement in quality of life has been demonstrated.
  • No comparative data versus the available targeted therapies (bevacizumab and cetuximab) are available.

 


Clinical Benefit

Moderate

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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