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

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no clinical added value

Therapeutic use

-

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