BUSILVEX (busulfan)
ONCOLOGY - Focus
Opinions on drugs -
Posted on
Oct 14 2016
Reason for request
Extension of inclusion and re-assessment of the actual benefit and the improvement in actual benefit
Conditioning treatment prior to conventional haematopoietic stem cell transplantation:
- No clinical benefit demonstrated in adults compared to other available conditioning regimens.
- Minor clinical benefit in infants, children and adolescents compared to total body irradiation.
- BUSILVEX has Marketing Authorisation in 3 indications for conditioning treatment prior to conventional haematopoietic stem cell (HSC) transplantation:
- BUSILVEX followed by cyclophosphamide in adults,
- BUSILVEX followed by cyclophosphamide or melphalan in infants, children and adolescents,
- BUSILVEX administered after fludarabine in adults eligible for a reduced intensity conditioning (RIC).
- New data confirm that busulfan IV-based regimens are an effective therapeutic strategy in the myeloablative conditioning treatment of infants, children and adolescents and adults, as well as in reduced intensity conditioning in adults.
- Busulfan IV-based conditioning regimens prior to HSC transplantation are first-line treatments.
Clinical Benefit
Substantial |
- |
Clinical Added Value
minor |
- |
no clinical added value |
Therapeutic use
- |
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