Reason for request

Extension of indication

No clinical added value demonstrated in comparison with daunorubicin in induction therapy for newly diagnosed acute myeloid leukaemia in children

 

  • ZAVEDOS, in combination with cytarabine, now has marketing authorisation in the 1st-line setting for remission induction in previously untreated children with acute myeloid leukaemia (AML).
  • As in adults, anthracyclines play a key role in chemotherapy regimens, particularly induction for AML.
  • In the context of induction regimens, intravenous idarubicin is an alternative to daunorubicin in the treatment of previously untreated childhood AML.

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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