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XTANDI® (Enzalutamide): a Treatment Option for Castration-Resistant Prostate Cancer (CRPC)

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XTANDI® (Enzalutamide): a Treatment Option for Castration-Resistant Prostate Cancer (CRPC) XTANDI® (enzalutamide): A Treatment Option for Castration-Resistant Prostate Cancer (CRPC) XTANDI® (enzalutamide) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with castration-resistant prostate cancer (CRPC).1 XTANDI is the first and only oral medication FDA-approved for both non-metastatic and metastatic CRPC.1 ABOUT THE ASTELLAS/PFIZER HOW XTANDI WORKS COLLABORATION Astellas and Pfizer jointly XTANDI is indicated for the treatment of CRPC, commercialize XTANDI which is defined as disease progression on in the United States. androgen deprivation therapy (luteinizing hormone-releasing hormone (LHRH) therapy Astellas has responsibility or prior bilateral orchiectomy).2 for manufacturing and all additional regulatory In prostate cancer, the androgen receptor (AR) is a key driver filings globally, as well as of progression.3 XTANDI is an AR inhibitor that is thought commercializing XTANDI to act on multiple steps of the androgen receptor signaling 1 outside the United States. pathway within the tumor cell based on in vitro studies. Select Safety Information Seizure occurred in 0.4% of patients receiving XTANDI in clinical studies. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. Patients in the study had one or more of the following pre-disposing factors: use of medications that may lower the seizure threshold; history of traumatic brain or head injury, cerebrovascular accident or transient ischemic attack, Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment. Please see additional Important Safety Information on pages 3 and 4 and click here for Full Prescribing Information. August 2018, 076-3315-PM XTANDI® (enzalutamide): A Treatment Option for Castration-Resistant Prostate Cancer (CRPC) NON-METASTATIC CRPC CLINICAL TRIAL PROSPER PROSPER was a multinational, randomized, double-blind, placebo-controlled trial that enrolled 1,401 patients with non-metastatic castration-resistant prostate cancer (nmCRPC) that had progressed, based on ≥ 3 rising prostate-specific antigen (PSA) values despite castrate testosterone levels (≤ 50 ng/dL) and a PSA doubling time ≤ 10 months. Patients in this trial were chemotherapy naive and had no symptoms or minimal symptoms and no prior or present evidence of metastatic disease.1,4 Results of the study, which supported the FDA approval of XTANDI for use in patients with nmCRPC,1 demonstrated XTANDI plus LHRH therapy*: • Reduced the risk of metastasis or death by 71 percent (HR=0.29 [95% CI, 0.24-0.35]; P<0.0001).1 • Improved median metastasis-free survival. Median metastasis-free survival (MFS) was 36.6 months (95% CI, 33.1-Not reached (NR)) for men who received XTANDI compared to 14.7 months (95% CI: 14.2-15.0) for men who received placebo plus ADT (HR=0.29 [95% CI: 0.24-0.35]; P < 0.0001).1 Metastasis-free survival was defined as the time from randomization to whichever of the following occurred first 1) loco-regional and/or distant radiographic progression per biochemical recurrence (BICR) or 2) death up to 112 days after treatment discontinuation without evidence of radiographic progression.1 METASTATIC CRPC CLINICAL TRIALS AFFIRM PREVAIL TERRAIN AFFIRM was a multinational, randomized, PREVAIL was a multinational, randomized, TERRAIN was a multinational, double- double-blind, placebo-controlled study double-blind, placebo-controlled trial in blind, randomized study in 375 in 1,199 men with metastatic CRPC who 1,717 chemotherapy-naive patients with chemotherapy-naive patients with had previously received docetaxel-based metastatic CRPC and asymptomatic or metastatic CRPC asymptomatic or mildly chemotherapy and had asymptomatic to mildly symptomatic disease. Patients were symptomatic disease. Patients were moderately symptomatic disease. Patients randomized to receive XTANDI plus LHRH randomized to receive XTANDI plus LHRH were randomized to receive XTANDI plus therapy* (n = 872) or placebo plus LHRH therapy* (n = 184) or bicalutamide plus LHRH therapy* (n = 800) or placebo plus therapy* (n = 845).6 LHRH therapy* (n = 191).7 LHRH therapy* (n = 399).5 Results of the study demonstrated Results of the study demonstrated Results of the study demonstrated XTANDI plus LHRH therapy: XTANDI plus LHRH therapy: XTANDI plus LHRH therapy: • Improved overall survival. Median • Reduced the risk of radiographic • Improved overall survival. Median overall survival was 35.3 months progression or death by 40% Overall Survival (OS) post-docetaxel (95% CI, 32.2-NR) for patients receiving compared with bicalutamide plus was 18.4 months (95% CI, 17.3-NR) XTANDI plus LHRH therapy* compared LHRH therapy* (HR = 0.60 [95% CI, compared to 13.6 months (95% CI, to 31.3 months (95% CI, 28.8-34.2) 0.43-0.83]).1 11.3-15.8) with placebo plus LHRH for those receiving placebo plus LHRH therapy,* (HR = 0.63 [95% CI, 0.53- therapy* (HR = 0.77 [95% CI, 0.67- 0.75]; P < 0.0001).1 0.88]).1 • Significantly reduced the risk of radiographic progression or death by 83% compared with placebo plus LHRH therapy* (HR = 0.17 [95% CI, 0.14-0.21]; P < 0.0001).1 Select Safety Information Posterior Reversible Encephalopathy Syndrome (PRES) In post approval use, there have been reports of Posterior Reversible Encephalopathy Syndrome (PRES) in patients receiving XTANDI. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES. Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions. Please see additional Important Safety Information on pages 3 and 4 and click here for Full Prescribing Information. * *Or prior bilateral orchiectomy **Hazard radio (HR) indicates the relative risk of a complication based on comparison of event rates between treatment and control August 2018, 076-3315-PM XTANDI® (enzalutamide): A Treatment Option for Castration-Resistant Prostate Cancer (CRPC) HELPFUL INFORMATION ABOUT XTANDI DOSING The recommended XTANDI can be Steroids, for Patients receiving dose of XTANDI taken with or example oral XTANDI should also is four 40 mg without food1 prednisone, are receive an LHRH capsules (160 mg) not required analog concurrently taken orally, once with XTANDI1* or should have a day, at the same had bilateral time each day1 orchiectomy1 IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Falls and Fractures In the placebo-controlled clinical studies, falls occurred in 10% of patients treated with XTANDI compared to 4% of Seizure occurred in 0.4% of patients receiving XTANDI in clinical studies. In a study of patients with predisposing factors for seizure, patients treated with placebo. Fractures occurred in 8% of patients 2.2% of XTANDI-treated patients experienced a seizure. Patients in the treated with XTANDI and in 3% of patients treated with placebo. Evaluate study had one or more of the following pre-disposing factors: use of patients for fracture and fall risk. Monitor and manage patients at risk for medications that may lower the seizure threshold; history of traumatic fractures according to established treatment guidelines and consider use brain or head injury, cerebrovascular accident or transient ischemic of bone-targeted agents. attack, Alzheimer’s disease, meningioma, or leptomeningeal disease Embryo-Fetal Toxicity Safety and efficacy of XTANDI have not been from prostate cancer, unexplained loss of consciousness within the last established in females. XTANDI can cause fetal harm and loss of 12 months, history of seizure, presence of a space occupying lesion pregnancy when administered to a pregnant female. Advise males with of the brain, history of arteriovenous malformation, or history of brain female partners of reproductive potential to use effective contraception infection. It is unknown whether anti-epileptic medications will prevent during treatment with XTANDI and for 3 months after the last dose of seizures with XTANDI. Advise patients of the risk of developing a seizure XTANDI. XTANDI should not be handled by females who are or may while taking XTANDI and of engaging in any activity where sudden loss become pregnant. of consciousness could cause serious harm to themselves or others. ADVERSE REACTIONS Permanently discontinue XTANDI in patients who develop a seizure The most common adverse reactions (≥ 10%) that occurred more during treatment. frequently (≥ 2% over placebo) in the XTANDI patients
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