Medivation and Astellas Announce Phase 3 Study of Enzalutamide in Men With High-Risk, Hormone-Sensitive, Non-Metastatic Prostate Cancer That Has Recurred Following Definitive Local Therapy - Seite 2

The primary endpoint of the trial is metastasis-free survival. The trial will evaluate enzalutamide at a dose of 160 mg to be taken orally once daily. Leuprolide acetate will be given as an injection of 22.5 mg once every 12 weeks for a minimum of 3 doses. All patients will be treated for 37 weeks. Those achieving an undetectable PSA will suspend study drug(s). If the PSA rises again, study drug(s) will be restarted. Study drug treatment will then continue until disease progression.

Enzalutamide Mechanism of Action
Enzalutamide is an androgen receptor inhibitor that acts on three different steps in the androgen receptor signaling pathway.

About XTANDI^® (enzalutamide) capsules
XTANDI was initially approved by the Food and Drug Administration (FDA) on August 31, 2012 for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who have previously received docetaxel. On September 10, 2014, the FDA approved a new indication for XTANDI for the treatment of patients with metastatic CRPC.

Important Safety Information

Contraindications: XTANDI (enzalutamide) capsules can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. XTANDI is not indicated for use in women. XTANDI is contraindicated in women who are or may become pregnant.

Warnings and Precautions: In Study 1, conducted in patients with metastatic castration-resistant prostate cancer (CRPC) who previously received docetaxel, seizure occurred in 0.9% of patients who were treated with XTANDI and 0% treated with placebo. In Study 2, conducted in patients with chemotherapy-naïve metastatic CRPC, seizure occurred in 0.1% of patients who were treated with XTANDI and 0.1% treated with placebo. Patients experiencing a seizure were permanently discontinued from therapy and all seizure events resolved. There is no clinical trial experience re‐administering XTANDI to patients who experienced a seizure, and limited clinical trial experience in patients with predisposing factors for seizure. Study 1 excluded the use of concomitant medications that may lower threshold, whereas Study 2 permitted the use of these medications. Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity during which sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.