MYLERAN (busulfan), antineoplastic agent
Opinions on drugs - Posted on May 10 2017
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.
Évaluation des médicaments