This article summarizes the regulatory evaluation that led to the full approval of enzalutamide (XTANDI, Medivation Inc.) by the U.S. Food and Drug Administration (FDA) on August 31, 2012, for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. This approval was based on the results of a randomized, placebo-controlled trial whic...

Enzalutamide is a potent second-generation androgen receptor (AR) antagonist with activity in metastatic castrate-resistant prostate cancer (CRPC). Although enzalutamide is initially effective, disease progression inevitably ensues with the emergence of resistance. Intratumoral hypoxia is also associated with CRPC progression and treatment resistance. Given that both AR and hypoxia inducible fa...

The effects of enzalutamide monotherapy on prostate tumor downsizing and multiparametric MRI are currently unknown. Here we present the first case in literature of a patient with high-grade prostate cancer who underwent 3 months of neoadjuvant enzalutamide, for which the effects on mpMRI and histology were determined. Tumor size reduction and downstaging were noted. Neoadjuvant enzalutamide res...

BACKGROUND To present longitudinal changes in Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores during 25-week treatment with enzalutamide or placebo in men with progressive metastatic castration-resistant prostate cancer (mCRPC) after chemotherapy in the AFFIRM trial. PATIENTS AND METHODS Patients were randomly assigned to enzalutamide 160 mg/day or placebo. FACT-P was complet...

Background: Cabazitaxel, abiraterone, and enzalutamide are survival-prolonging treatments in men with castration-resistant prostate cancer (CRPC) progressing following docetaxel chemotherapy. The sequential activity of these agents has not been studied and treatment sequencing remains a key dilemma for clinicians. Objective: To describe the antitumour activity of cabazitaxel after docetaxel and...

BACKGROUND Abiraterone acetate and enzalutamide both improve outcomes in patients with metastatic castration-resistant prostate cancer (mCRPC). Optimal sequencing for these agents and whether cross-resistance occurs is unknown. METHODS Multicentre review of patients with mCRPC treated with abiraterone acetate and prednisone after progressing on enzalutamide. Primary objective was to determine...

Despite much progress in mCRPC treatment in recent years, optimal treatment sequences are still unclear, particularly in the post-abiraterone or post-enzalutamide treatment space. For men with bone-predominant disease (ie, no visceral or bulky nodal metastases) and symptomatic progression, current offprotocol options include crossover therapy to another oral novel hormonal agent (enzalutamide t...

OBJECTIVE To explore any differences in efficacy and safety outcomes between European (EU) (n = 684) and North American (NA) (n = 395) patients in the AFFIRM trial (NCT00974311). PATIENTS AND METHODS Phase III, double-blind, placebo-controlled, multinational AFFIRM trial in men with metastatic castration-resistant prostate cancer (mCRPC) after docetaxel. Participants were randomly assigned in...

Enzalutamide marks the latest addition to the drugs currently approved by the US Food and Drug Administration for metastatic, castration-resistant prostate cancer (mCRPC). AFFIRMwas a phase III international randomized trial that evaluated the clinical utility of enzalutamide versus placebo in men with mCRPC who have failed prior docetaxel-containing chemotherapy. Enzalutamide showed a remarkab...

PCN248 Cost-Utility ANAlysis of ENzAlUtAmidE for PAtiENts With ChEmothErAPy-NAïvE mEtAstAtiC CAstrAtioN-rEsistANt ProstAtE CANCEr (mCrPC) AftEr fAilUrE of ANdrogEN dEPrivAtioN thErAPy (Adt) Vicente C1, Loblaw A2, North S3, Kassouf W4, Naidoo S5, Husein F6, Nakhaipour HR6 1PIVINA Consulting Inc., Mississauga, ON, Canada, 2University of Toronto, Toronto, ON, Canada, 3University of Alberta, Edmont...