Provenge sipuleucel-T regulatory update

EMA's CHMP issued a positive opinion recommending approval of Provenge sipuleucel-T from Dendreon to treat asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (CRPC) in adults when chemotherapy is not yet clinically indicated. Dendreon expects a decision from the European Commission this half.

Provenge is an advanced therapy medicinal product (ATMP) and was evaluated by EMA's Committee for Advanced Therapies (CAT), which issued a positive opinion. CAT was established under 2007 legislation for the centralized regulation of gene therapy, stem cell therapy and tissue engineering products in the EU. ...