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ZAVEDOS (idarubicin), anthracycline

HAEMATOLOGY ONCOLOGY - New indication
Opinions on drugs - Posted on May 11 2017

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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