Inclusion on the list of medicines approved for hospital use.
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Clinical Benefit
Moderate
the Committee attributes to ARZERRA a moderate actual benefit, on a provisional basis, pending additional data.
Clinical Added Value
no clinical added value
In view of the limited clinical data based on : - efficacy results taken from a subgroup (n = 59) of a non-comparative phase II study, - a historical comparison with the results of a retrospective study, it is not possible to assess the therapeutic contribution of this medicinal product. Consequently, the transparency Committee believes that the medicinal product ARZERRA does not provide any improvement in actual benefit (IAB V) in the management of chronic lymphocytic leukaemia in patients refractory to fludarabine and alemtuzumab, on a provisional basis, pending additional data.
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