Astellas Pharma announced that the European Medicines Agency (EMA) has validated and started the review process for Astellas’ application for a Type II Variation for enzalutamide to extend the overall indication to include patients with non-metastatic castration-resistant prostate cancer (CRPC) based on results from the Phase 3 PROSPER trial.
Astellas announced first results for the PROSPER trial at the 2018 Genitourinary Cancers Symposium in February. Additional data from the PROSPER trial, including prostate-specific antigen (PSA) response rates and patient-reported outcome measures, will be presented at the upcoming 2018 European Association of Urology in Copenhagen.
Prostate cancer is the second most common cancer in men worldwide. More than 164,000 men in the United States are estimated to be newly diagnosed with prostate cancer in 2018. In the European Union, the estimated number of new prostate cancer cases in 2015 was 365,000.
Enzalutamide was first approved by the European Commission in June 2013 for the treatment of adult men with metastatic castration-resistent prostate cancer (mCRPC) whose disease has progressed on or after docetaxel therapy. Enzalutamide is also approved in Europe for the treatment of adult men with mCRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.