Reason for request

Renewal of inclusion

Insufficient clinical benefit in chronic myelogenous leukaemia and in conditioning regimens for stem cell transplantation

  

  • MYLERAN (orally administered busulfan) has marketing authorisation in the treatment of chronic myelogenous leukaemia that is refractory to other therapies, or where other therapies are contraindicated, and for conditioning prior to haematopoietic stem cell transplantation
  • In conditioning regimens for stem cell transplantation, MYLERAN no longer has a role in the therapeutic strategy because the oral form of busulfan has greater toxicity than the intravenous form.
  • In chronic myelogenous leukaemia, from the 2nd-line setting onwards, MYLERAN no longer has a role in the therapeutic strategy because more effective and better tolerated alternatives are available.

 

 


Clinical Benefit

Insufficient

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Therapeutic use

-

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