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Reason for request
Inclusion on the list of medicines approved for hospital use in extension of indication “in combination with pegylated liposomal doxorubicin (PLD) in the treatment of platinum-sensitive recurring ovarian cancer”.
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Clinical Benefit
| Substantial |
The actual benefit of these products is substantial. |
Clinical Added Value
| no clinical added value |
Taking into account the results of a subgroup analysis which showed an absolute gain of 2 months in progression-free survival with the combination of YONDELIS + pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone, without an improvement in overall survival and at the cost of an increase in haematological and hepatic toxicity, the Committee considers that this combination does not provide an improvement in actual benefit (level V) within the therapeutic strategy. |
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