Reason for request
Re-assessment of the IAB
-
Clinical Benefit
| Low |
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. |
