Reason for request

Re-assessment of the IAB

-


Clinical Benefit

Low

that the actual benefit of METASTRON is low in the Marketing Authorisation indication, namely: “as an adjunct or alternative to external radiotherapy in the palliative treatment of pain associated with bone metastases secondary to prostate cancer in patients in whom hormone therapy has failed”.


Clinical Added Value

no clinical added value

The proprietary medicinal product METASTRON, as an adjunct or alternative to radiotherapy, does not provide any improvement in actual benefit (IAB V, nonexistent) in the strategy for the management of pain from bone metastases associated with prostate cancer in patients in whom hormone therapy has failed.