TOKYO – March 16, 2018 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today 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.

“In many cases, men see their prostate cancer progress after initial androgen deprivation therapy. Until recently, no treatments have been proven efficacious for men with unproven metastatic disease castration-resistant prostate cancer,” said Dr Cora N. Sternberg, a key investigator in the trial and Chief of Medical Oncology at San Camillo Forlanini Hospital, Italy. “The PROSPER data may help us better understand this challenging stage of the disease.”

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.

About PROSPER
The Phase 3 randomized, double-blind, placebo-controlled, multi-national trial enrolled approximately 1,400 patients with non-metastatic castration-resistant prostate cancer (CRPC) at sites in the United States, Canada, Europe, South America and the Asia-Pacific region. PROSPER enrolled patients with prostate cancer that had progressed, based on a rising prostate-specific antigen (PSA) level despite androgen deprivation therapy (ADT), but who had no symptoms and no prior or present evidence of metastatic disease. The trial evaluated enzalutamide at a dose of 160 mg taken orally once daily plus ADT, versus placebo plus ADT. 

The primary endpoint of the PROSPER trial, metastasis-free survival (MFS), is a measure of the amount of time that passes until a cancer can be radiographically detected as having metastasized, or until death, within 112 days of treatment discontinuation. Some secondary endpoints included time to PSA progression, time to first use of antineoplastic therapy and overall survival.

For more information on the PROSPER trial, go to www.clinicaltrials.gov.

About Prostate Cancer
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.

Castration-resistant prostate cancer (CRPC) refers to the subset of men whose prostate cancer progresses despite castration levels of testosterone.  Non-metastatic CRPC means there is no clinically detectable evidence of the cancer spreading to other parts of the body (metastases), and there is a rising prostate-specific antigen (PSA) level.  Many men with non-metastatic CRPC and a rapidly rising PSA level go on to develop metastatic CRPC.

About Enzalutamide
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.

Important Safety Information for Enzalutamide
For important Safety Information for enzalutamide please see the full Summary of Product Characteristics at: https://www.medicines.org.uk/emc/product/3203.