IQWiG amends findings on Provenge in Dendreon's favor

Germany's health technology appraisal body IQWiG has amended its view of Dendreon's cell therapy for prostate cancer, Provenge (sipuleucel-T), declaring now that there is an indication of added benefit, although this is "non-quantifiable". It had recently found Provenge to show no proven additional benefit compared with existing comparators. The revised opinion came after Dendreon submitted additional information to show a more consistent picture of lower mortality in the Provenge arms compared with placebo, when patients received docetaxel with docetaxel on progression of their disease. The product was approved in September 2014 for men with metastatic prostate cancer who have few or no symptoms and do not yet require chemotherapy. Although the overall survival advantage was accompanied by more frequent side-effects of fever, headache and chills with Provenge, these were non-serious and mainly occurred directly after the administration of Provenge, so IQWiG did not downgrade the positive mortality effect. It is down to the G-BA, which is in charge of assessments, to make a final decision on the extent of added benefit.