IQWiG reports negative views on Provenge, Velphoro and Zydelig

The German Institute for Quality and Efficiency in Health Care (IQWiG) has reviewed a number of dossiers to assess whether the drugs offer patients an added benefit over one of the appropriate comparator therapies.

According to the findings on USA-based Dendreon’s (Nasdaq: DNDN) Provenge (sipuleucel-T), an added benefit is not proven: The data on mortality were not evaluable because differences between the treatment groups might have been caused by the circumstances of the subsequent therapies. At the same time, certain side effects such as fever occur more frequently.

Sipuleucel-T is an option for patients whose cancer has already formed metastases and can also no longer be influenced by blocking the hormone testosterone (hormone refractory). Overall, the negative effects do not result in “lesser benefit”, however, because the uncertainty in the outcome “overall survival” is so high that no conclusive weighing is possible. Hence an added benefit of sipuleucel-T versus the appropriate comparator therapy, watchful waiting while maintaining hormone blockade, is not proven, the IQWiG concluded.