Provenge sipuleucel-T regulatory update

Germany’s Institute for Quality and Efficiency in Healthcare (IQWiG) said in an early benefit assessment that the added benefit of prostate cancer drug Provenge sipuleucel-T from Dendreon was not proven. The agency said data on mortality were not evaluable because “differences between the treatment groups might have been caused by the circumstances of the subsequent therapies” and that certain side effects occur more frequently. Provenge is approved in the U.S. and EU to treat metastatic castration-resistant prostate cancer (CRPC) in patients who are asymptomatic or minimally symptomatic. ...