Affirm study enzalutamide mechanism

Evidence for the efficacy of enzalutamide in ...

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In addition, enzalutamide does not require coadministration with corticosteroids. In this review of enzalutamide for mCRPC, the mechanism of action, early phase development, registrational phase III AFFIRM study in the mCRPC postchemotherapy setting, …

Evidence for the efficacy of enzalutamide in ...

Increased Survival with Enzalutamide in Prostate Cancer ...

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The AFFIRM (A Study Evaluating the ... channel is a hypothesized mechanism by which enzalutamide lowers the seizure threshold. 27 Caution should be used in administering enzalutamide to patients ...

Increased Survival with Enzalutamide in Prostate Cancer ...

AFFIRM Trial Study Design - XTANDI® (enzalutamide)

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The primary endpoint in AFFIRM was overall survival, and patients were first assessed for disease progression at 13 weeks. 2. AFFIRM was a randomized (2:1), double-blind, placebo-controlled study for patients on LHRH therapy* who had progressed to metastatic CRPC. Patients with predisposing factors for seizure history were excluded.

AFFIRM Trial Study Design - XTANDI® (enzalutamide)

An update on enzalutamide in the treatment of prostate cancer

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Enzalutamide is an oral androgen receptor inhibitor that targets multiple steps in the androgen receptor signaling pathway. In the randomized phase III AFFIRM study, significant improvements in survival versus placebo were observed when enzalutamide was used as a treatment for patients with ...

An update on enzalutamide in the treatment of prostate cancer

A Comparison of Rate Control and Rhythm Control in ...

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In the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study, we compared the effects of long-term treatment with these two strategies. 3,22,23. Methods.

A Comparison of Rate Control and Rhythm Control in ...

Enzalutamide - Wikipedia

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Enzalutamide, sold under the brand name Xtandi, is a nonsteroidal antiandrogen (NSAA) medication which is used in the treatment of prostate cancer. It is indicated for use in conjunction with castration in the treatment of metastatic castration-resistant prostate cancer (mCRPC) and nonmetastatic castration-resistant prostate cancer. It is taken by mouth.

Enzalutamide - Wikipedia

AFFIRM Trial Adverse Reactions - XTANDI® (enzalutamide ...

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Most Common Adverse Reactions from the AFFIRM Trial 1 ... (enzalutamide) is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC). ... hot flush, arthralgia, dizziness/vertigo, hypertension, headache and weight decreased. In the bicalutamide-controlled study, the most common adverse reactions (≥ 10% ...

AFFIRM Trial Adverse Reactions - XTANDI® (enzalutamide ...

Evidence for the efficacy of enzalutamide in ...

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The treatment of metastatic castrate-resistant prostate cancer (mCRPC) has evolved rapidly with the recent approval of a number of treatments and agents, including docetaxel, sipuleucel T, abiraterone, cabazitaxel, and enzalutamide. Enzalutamide (previously MDV-3100) is a novel oral androgen receptor inhibitor that targets multiple steps in the androgen receptor signaling pathway.

Evidence for the efficacy of enzalutamide in ...

Emerging mechanisms of enzalutamide resistance in prostate ...

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AFFIRM study demonstrated an average ... splicing is a naturally occurring mechanism ... Emerging mechanisms of enzalutamide resistance in prostate cancer Frank Claessens, Christine Helsen, Stefan ...

Emerging mechanisms of enzalutamide resistance in prostate ...

Enzalutamide - an overview | ScienceDirect Topics

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Enzalutamide does this even when androgen receptors are over-expressed in prostate cancer cells that are resistant to anti-androgens. In the AFFIRM study enzalutamide the overall incidences of adverse events were comparable to placebo [66 C].

Enzalutamide - an overview | ScienceDirect Topics

(PDF) Emerging mechanisms of enzalutamide resistance in ...

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Emerging mechanisms of enzalutamide resistance in prostate cancer ... AFFIRM study demonstrated ... suggesting that aberrant HMGCR expression is an important enzalutamide resistance mechanism in ...

(PDF) Emerging mechanisms of enzalutamide resistance in ...

Efficacy and safety of enzalutamide versus bicalutamide ...

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Background Enzalutamide is an oral androgen-receptor inhibitor that has been shown to improve survival in two placebo-controlled phase 3 trials, and is approved for patients with metastatic castration-resistant prostate cancer. The objective of the TERRAIN study was to compare the effi cacy and safety of enzalutamide with bicalutamide in

Efficacy and safety of enzalutamide versus bicalutamide ...

Clinical activity and tolerability of enzalutamide ...

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However, in contrast, diarrhea was an infrequent AE in the current study, and musculoskeletal pain was more common than in the AFFIRM study. Our small retrospective study has several limitations, including selection bias, variable assessment intervals, incomplete data on the efficacy and tolerability of Enz, and a relatively short follow-up.

Clinical activity and tolerability of enzalutamide ...

Evidence for the efficacy of enzalutamide in ...

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In addition, enzalutamide does not require coadministration with corticosteroids. In this review of enzalutamide for mCRPC, the mechanism of action, early phase development, registrational phase III AFFIRM study in the mCRPC postchemotherapy setting, and ongoing clinical development will be discussed. Enzalutamide mechanism of action

Evidence for the efficacy of enzalutamide in ...

Enzalutamide: A new prostate cancer targeted therapy ...

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Enzalutamide has a much higher affinity for the AR receptor than first-generation antiandrogens , with no agonist activity and demonstrates activity even in case of amplification and overexpression of the AR, which are well known mechanisms involved in androgenic castration resistance .Enzalutamide inhibits the AR signalling pathway and is a competitor inhibitor of dihydrotestosterone (DHT ...

Enzalutamide: A new prostate cancer targeted therapy ...

Enzalutamide: A Novel Antiandrogen for Patients with ...

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3/15/2013 · Late Clinical Development. AFFIRM, a phase III study evaluating the efficacy and safety of investigational drug enzalutamide (NCT00974311), compared enzalutamide with placebo and randomized (in a 2:1 ratio) 1,199 men with CRPC who progressed on at least one prior chemotherapy from September 2009 through November 2010 at 156 centers in 15 countries ().

Enzalutamide: A Novel Antiandrogen for Patients with ...

Efficacy and safety of enzalutamide versus bicalutamide ...

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1/13/2016 · Data from both the AFFIRM and PREVAIL trials of enzalutamide, published in 2012 and 2014, respectively, have subsequently shown that enzalutamide has a significant benefit over placebo in terms of overall survival and radiographic progression-free survival, as well as objective tumour response in patients with measurable soft tissue disease.

Efficacy and safety of enzalutamide versus bicalutamide ...

Clinical activity and tolerability of enzalutamide ...

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Like in the AFFIRM study, fatigue was the most frequent AE, and all hot flushes were grade 1. 7 However, in contrast, diarrhea was an infrequent AE in the current study, and musculoskeletal pain was more common than in the AFFIRM study. Our small retrospective study has several limitations, including selection bias, variable assessment ...

Clinical activity and tolerability of enzalutamide ...

Medivation and Astellas Announce New Data From XTANDI(R ...

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9/30/2012 · The data from the randomized, global, placebo-controlled phase 3 AFFIRM study highlight the effect of enzalutamide on pain-related secondary endpoints and a post hoc analysis of the survival ...

Medivation and Astellas Announce New Data From XTANDI(R ...

Enzalutamide - Search Livertox Database

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7/5/2017 · Enzalutamide is a nonsteroidal antiandrogen used to treat metastatic castration-resistant prostate cancer. Enzalutamide is associated with a low rate of serum enzyme elevation during therapy, but has not been linked to cases of clinically apparent liver injury with jaundice. Background

Enzalutamide - Search Livertox Database

Advanced prostate cancer – patient survival and potential ...

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5/27/2014 · Advanced prostate cancer – patient survival and potential impact of enzalutamide and other emerging therapies Nihar K Patel, Antoine Finianos, Kristen D Whitaker, Jeanny B Aragon-Ching Department of Medicine, Division of Hematology and Oncology, George Washington University Medical Center, Washington, DC, USA Abstract: The advent of exponential growth of novel agents tested and …

Advanced prostate cancer – patient survival and potential ...

[Full text] Enzalutamide for patients with metastatic ...

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1/7/2015 · Enzalutamide for patients with metastatic castration-resistant prostate cancer Wijdan H Ramadan,1 Wissam K Kabbara,1 Hiba S Al Basiouni Al Masri2 1Department of Pharmacy Practice, School of Pharmacy, Lebanese American University, Byblos, Lebanon; 2School of Pharmacy, Beirut Arab University, Beirut, Lebanon Objective: To review and evaluate current literature on the US Food and …

[Full text] Enzalutamide for patients with metastatic ...

XTANDI™ (Enzalutamide) Authorized in the European Union ...

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6/24/2013 · The study also concluded that enzalutamide was generally well tolerated by patients and met all secondary endpoints. The Phase 3 AFFIRM trial was a randomized, double-blind, placebo-controlled ...

XTANDI™ (Enzalutamide) Authorized in the European Union ...

HIGHLIGHTS OF PRESCRIBING INFORMATION Posterior reversible ...

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12.1 Mechanism of Action ... Patients in the study had one or more of the following pre-disposing factors: the use of ... enzalutamide in four randomized clinical trials [see Adverse Reactions (6.1)]. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily ...

HIGHLIGHTS OF PRESCRIBING INFORMATION Posterior reversible ...

Efficacy of Enzalutamide Following Abiraterone Acetate in ...

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The findings of this study point to a common mechanism of resistance to enzalutamide in docetaxel-experienced and -naive patients. Resistance mechanisms to enzalutamide include ... Saad, F. et al. Impact of on-study corticosteroid use on efficacy and safety in the phase III AFFIRM study of enzalutamide (ENZA), an androgen receptor ...

Efficacy of Enzalutamide Following Abiraterone Acetate in ...

Medivation and Astellas Announce New Data From XTANDI ...

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Medivation and Astellas Announce New Data From XTANDI® (enzalutamide) Pivotal Study . AFFIRM Study Data Presented Today at European Society of Medical Oncology (ESMO) ... XTANDI Mechanism of …

Medivation and Astellas Announce New Data From XTANDI ...

Molecular Pathways: Targeting Resistance in the Androgen ...

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2/15/2014 · Androgen receptor signaling is critical in the development and progression of prostate cancer, leading to intensive efforts to elucidate all potential points of inflection for therapeutic intervention. These efforts have revealed new mechanisms of resistance and raise the possibility that known mechanisms may become even more relevant in the context of effective androgen receptor suppression.

Molecular Pathways: Targeting Resistance in the Androgen ...

Enzalutamide Improves Survival in Patients with Metastatic ...

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Enzalutamide is approved by the FDA for the treatment of men with metastatic castrate-resistant prostate cancer that is no longer responding to chemotherapy. However, chemotherapy is not a treatment option for many men with pre-existing medical conditions or who cannot tolerate the side effects. The Study

Enzalutamide Improves Survival in Patients with Metastatic ...

Enzalutamide: Next New Drug for Prostate Cancer?

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Enzalutamide looks set to be the next new drug. ... This is the indication explored in AFFIRM. The study of 1199 patients showed that enzalutamide ... with a defined mechanism of action and ...

Enzalutamide: Next New Drug for Prostate Cancer?

Medivation and Astellas Announce New Data From XTANDI(R ...

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9/30/2012 · Medivation Inc. and Astellas Pharma Inc. announced that new data for enzalutamide , an oral androgen receptor inhibitor, were presented today at the 2012 European Society of Medical Oncology ...

Medivation and Astellas Announce New Data From XTANDI(R ...

Enzalutamide In Castration Resistant Prostate Cancer ...

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AFFIRM test. A Study Evaluating the Efficacy and Safety of the Investigational Drug MDV3100 ( AFFIRM ) was an international stage 3, randomized, double-blinded, placebo-controlled survey that evaluated the usage of enzalutamide in patients with castrate immune prostate malignant neoplastic disease.

Enzalutamide In Castration Resistant Prostate Cancer ...

Medivation Enzalutamide Prostate cancer AFFIRM ...

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Mechanism of action: Xtandi (Enzalutamide) (MDV3100) is an orally bioavailable, organic, non-steroidal small molecule targeting the androgen receptor (AR) with potential antineoplastic activity. Through a mechanism that is reported to be different from other approved AR antagonists, enzalutamide inhibits the activity of prostate cancer cell ARs ...

Medivation Enzalutamide Prostate cancer AFFIRM ...

(PDF) Emerging mechanisms of enzalutamide resistance in ...

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PERSPECTIVES OPINION Enzalutamide resistance ADT and treatment with AR antagonists Emerging mechanisms of enzalutamide have the same goal: lowering AR signal- ling either indirectly by depriving the resistance in prostate cancer receptor of its ligand or directly by block- ing receptor activity.

(PDF) Emerging mechanisms of enzalutamide resistance in ...

Medivation Contacts: Astellas Contacts

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Title: Impact of on-study corticosteroid use on efficacy and safety in the phase 3 AFFIRM study of enzalutamide, an androgen receptor inhibitor (Abstract #6) • A . post-hoc. analysis of AFFIRM, a randomized, multinational, placebo-controlled phase 3 study among patients with mCRPC who had previously received docetaxel, showed that

Medivation Contacts: Astellas Contacts

POSITIVE CHMP OPINION FOR XTANDI (ENZALUTAMIDE) IN ...

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Enzalutamide is a novel, once-daily, oral androgen receptor inhibitor. It inhibits multiple steps in the androgen receptor (AR) signaling pathway, which has been shown preclinically to decrease ...

POSITIVE CHMP OPINION FOR XTANDI (ENZALUTAMIDE) IN ...

Antitumour activity of abiraterone acetate against ...

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4/10/2013 · Enzalutamide is a specific inhibitor of the AR, blocking testosterone binding to the AR, impeding nuclear translocation and inhibiting AR binding to DNA [4, 8]. In the phase III AFFIRM trial, 1199 men with CRPC who had received prior docetaxel-based chemotherapy were randomly assigned to either enzalutamide (160 mg/day) or placebo.

Antitumour activity of abiraterone acetate against ...

New England Journal of Medicine Publishes Results from ...

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6/1/2014 · Enzalutamide Mechanism of Action Enzalutamide is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway. Enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors, and inhibit androgen receptor nuclear translocation and interaction with DNA.

New England Journal of Medicine Publishes Results from ...

Medivation, Inc. and Astellas Pharma Inc. Announce New ...

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Medivation, Inc. and Astellas Pharma Inc. Announce New Data From XTANDI® (enzalutamide) Pivotal Study - read this article along with other careers information, tips and advice on BioSpace

Medivation, Inc. and Astellas Pharma Inc. Announce New ...

DailyMed - XTANDI- enzalutamide capsule

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12.1 Mechanism of Action. Enzalutamide is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway. Enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors; and consequently, inhibits nuclear translocation of androgen receptors and their interaction with DNA.

DailyMed - XTANDI- enzalutamide capsule

U.S. FDA Approves New Indication For The Use of XTANDI ...

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9/10/2014 · U.S. FDA Approves New Indication for the Use of XTANDI ® (enzalutamide) Capsules for Patients with Metastatic Castration-Resistant Prostate Cancer Approval based on improved overall survival, delayed time to radiographic progression and an overall positive benefit-risk profile

U.S. FDA Approves New Indication For The Use of XTANDI ...

PowerPoint slides - Research To Practice

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PowerPoint slides - Research To Practice + Report. ... Abstract 4519 Phase III AFFIRM Study Enzalutamide (160 mg/d) Eligibility (n = 1,199) • Patients with mCRPC • Failure of docetaxel- (n = 800) 2:1 R based chemotherapy Placebo (n = 399) De Bono JS et al. Proc ASCO 2012;Abstract 4519. ... radium-223/docetaxel on a clinical trial ...

PowerPoint slides - Research To Practice

Enzalutamide in castrate-resistant prostate cancer after ...

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reported AFFIRM study showed that enzalutamide treat-ment after chemotherapy significantly prolonged overall survival (OS), radiographic progression-free survival ... During the study, 48% of enzalutamide patients and 46% of placebo patients re- ... more treatment option with a different mechanism of action. — Jame Abraham, MD

Enzalutamide in castrate-resistant prostate cancer after ...
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