Reason for request

Re-assessment of the IAB


Clinical Benefit


The actual benefit of PROLEUKIN is low in the Marketing Authorisation indication.

Clinical Added Value

no clinical added value

In view of :

-     The limited available data (old, uncontrolled studies)

-     the absence of specific data in the current Marketing Authorisation population and for the validated dosages,

but considering that PROLEUKIN may have a (marginal) role in the therapeutic strategy,

the Committee considers that these proprietary medicinal products do not provide any improvement in actual benefit (level V, non-existent) in the current management of patients with metastatic renal cell carcinoma.