Sipuleucel-T (Provenge) has been authorised since September 2014 for use by men with metastatic prostate cancer who have little or no complaints and have no need for chemotherapy. The Institute for Quality and Efficiency in Health Care (IQWiG) has reviewed a dossier to determine whether the drug offers patients an additional benefit over appropriate comparator therapies.

An additional benefit has not been established: The mortality data are not usable because differences between the treatment groups could be based on the circumstances of the episode therapies. At the same time certain side effects such as fever occur frequently.

For more details, go to: https://www.iqwig.de/de/presse/pressemitteilungen/pressemitteilungen/sipuleucel-t-bei-prostatakrebs-zusatznutzen-ist-nicht-belegt.6515.html?&et_cid=4&et_lid=%25208 [German]