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Bram L T Ramaekers, Rob Riemsma, Florian Tomini, Thea van Asselt, Sohan Deshpande, Steven Duffy, Nigel Armstrong, Johan L Severens, Jos Kleijnen, Manuela A Joore
The National Institute for Health and Care Excellence (NICE) invited Janssen, the company manufacturing abiraterone acetate (AA; tradename Zytiga(®)), to submit evidence for the clinical and cost effectiveness of AA in combination with prednisone/prednisolone (AAP) compared with watchful waiting (i.e. best supportive care [BSC]) for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). Kleijnen Systematic Reviews Ltd (KSR), in collaboration with Maastricht University Medical Center, was commissioned as the Evidence Review Group (ERG)...
August 26, 2016: PharmacoEconomics
Trevor M Penning, Daniel Tamae
PURPOSE OF REVIEW: Androgen deprivation therapy is a cornerstone in the treatment of advanced prostate cancer and has extended the lives of countless patients. Unfortunately, many of these patients eventually succumb to metastatic castration-resistant prostate cancer (mCRPC). The efficacy of abiraterone acetate (AA, Zytiga) and enzalutamide (Enza, Xtandi) in the mCRPC setting prove that these tumors remain androgen-driven. We review recent studies that have shown that intratumoral androgen biosynthesis plays a significant role in the ever-evolving mCRPC tumor and we discuss the therapeutic implications of these findings...
June 2016: Current Opinion in Endocrinology, Diabetes, and Obesity
Johanna Svensson, Emelie Andersson, Ulf Persson, Thomas Edekling, Anna Ovanfors, Göran Ahlgren
OBJECTIVE: In a randomized clinical trial (COU-AA-301), abiraterone acetate (Zytiga(®)) was shown to be superior to prednisone in the treatment of metastatic castration-resistant prostate cancer (mCRPC). However, the value of abiraterone treatment for patients with mCRPC in clinical practice in Sweden is not known. The aim of this study was to compare the outcomes and treatment patterns of abiraterone treatment in a Swedish observational study to those of the pivotal clinical trial, thereby discussing the external validity of the postchemotherapy clinical trial from a Swedish perspective...
August 2016: Scandinavian Journal of Urology
Thenappan Chandrasekar, Joy C Yang, Allen C Gao, Christopher P Evans
Despite advances in prostate cancer diagnosis and management, morbidity from prostate cancer remains high. Approximately 20% of men present with advanced or metastatic disease, while 29,000 men continue to die of prostate cancer each year. Androgen deprivation therapy (ADT) has been the standard of care for initial management of advanced or metastatic prostate cancer since Huggins and Hodges first introduced the concept of androgen-dependence in 1972, but progression to castration-resistant prostate cancer (CRPC) occurs within 2-3 years of initiation of ADT...
June 2015: Translational Andrology and Urology
Frank dela Rama, Caroline Pratz
BACKGROUND: Treatment of metastatic castration-resistant prostate cancer (mCRPC) has evolved rapidly. In particular, five new treatments that extend survival in mCRPC have been approved since 2010, including the chemotherapy cabazitaxel (Jevtana®), hormonal agents abiraterone (Zytiga®) and enzalutamide (Xtandi®), vaccine sipuleucel-T (Provenge®), and radiopharmaceutical radium-223 (Xofigo®); all have different indications and toxicity profiles. OBJECTIVES: This review discusses treatment advances in mCRPC, including considerations for side-effect management and treatment sequencing...
December 2015: Clinical Journal of Oncology Nursing
Michiko Iwata, Kenichiro Tsutsumi, Yasushi Harada
No abstract text is available yet for this article.
May 2015: Nihon Yakurigaku Zasshi. Folia Pharmacologica Japonica
Tian Zhang, Jason Zhu, Daniel J George, Andrew J Armstrong
INTRODUCTION: Over the past decade, treatment options for men with metastatic castration-resistant prostate cancer (CRPC) have expanded with the addition of abiraterone acetate (AA), enzalutamide, sipuleucel-T, radium-223, docetaxel and cabazitaxel. The optimal sequencing of therapies in the context of efficacy and known cross-resistance remains uncertain. AREAS COVERED: We review the development of enzalutamide (MDV3100, Xtandi), a novel second-generation androgen receptor (AR), and AA (Zytiga), a selective, irreversible inhibitor of cytochrome P17...
March 2015: Expert Opinion on Pharmacotherapy
Benyi Li, Aijing Sun, Wencong Jiang, J Brantley Thrasher, Paul Terranova
Prostate cancers in the castration-resistant stage are life-threatening because they are not curable in clinic. The novel androgen receptor inhibitor Xandi (Enzalutamide) and the new CYP17 inhibitor Zytiga (Abiraterone) prolonged patient survival only a few months in advanced prostate cancers. Therefore, novel therapeutic agents for advanced prostate cancers are urgently needed. PI-3 kinases are major intracellular signaling molecules that regulate multiple signal pathways related to cellular metabolism, cytokinesis, growth and survival...
2014: American Journal of Clinical and Experimental Urology
Yukiko Nishimura, Harumi Mukai, Kazumi Suzukawa, Ryo Oyama
Abiraterone acetate(AA)has been approved in more than 80 countries for the treatment of patients with metastatic castration-resistant prostate cancer(mCRPC). In July 2013, a marketing approval application for AA was submitted to the Japanese Ministry of Health, Labour, and Welfare. AA is a selective inhibitor of CYP17A1, a crucial enzyme for androgen biosynthesis. AA exerts its anti-tumor activity by directly inhibiting androgen production at all three sources, i. e., the testes, adrenal glands, and tumor itself...
July 2014: Gan to Kagaku Ryoho. Cancer & Chemotherapy
Alexandre V Ivachtchenko, Oleg D Mitkin, Elizaveta V Kudan, Alexey A Rjahovsky, Anton A Vorobiev, Andrey S Trifelenkov, Natalia A Shevkun, Oxana V Proskurina, Dmitry V Kravchenko, Ruben N Karapetian
Recently new drugs targeting androgen-dependent axis have been approved for the treatment of castration-resistant prostate cancer (CRPC) - Zytiga and Xtandi (formerly MDV3100), several other candidates (for example, ARN-509) are in early phases of clinical trials. However despite significant improvement in overall survival with new treatments it is evident that resistance to these drugs develops. One of the approaches to overcome it is combination therapy and from this point of view some potential for drug-drug interactions can limit the application of the drug...
2014: Journal of Cancer
Sheridan M Hoy
Abiraterone acetate (Zytiga(®)) is an orally administered, selective inhibitor of the 17α-hydroxylase and C17,20-lyase enzymatic activities of cytochrome P450 (CYP) 17. CYP17 is required for androgen biosynthesis, with androgen receptor signalling crucial in the progression from primary to metastatic prostate cancer. Abiraterone acetate is approved in the European Union and the US, in combination with prednisone or prednisolone, for the treatment of men with metastatic castration-resistant prostate cancer (CRPC)...
December 2013: Drugs
Paul G Kluetz, Yang-Min Ning, V Ellen Maher, Lijun Zhang, Shenghui Tang, Debasis Ghosh, Robeena Aziz, Todd Palmby, Elimika Pfuma, Jeanne Fourie Zirkelbach, Nitin Mehrotra, Amy Tilley, Rajeshwari Sridhara, Amna Ibrahim, Robert Justice, Richard Pazdur
On December 10, 2012, the U.S. Food and Drug Administration granted full approval for a modified indication for abiraterone acetate (Zytiga tablets; Janssen Biotech, Inc.) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). The approval was based on clinical trial COU-AA-302, which randomly allocated asymptomatic or mildly symptomatic patients with chemotherapy-naïve mCRPC and no visceral metastases to either abiraterone acetate plus prednisone (N = 546) or placebo plus prednisone (N = 542)...
December 15, 2013: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Tamara Goldberg, Evangelina Berrios-Colon
No abstract text is available yet for this article.
January 2013: P & T: a Peer-reviewed Journal for Formulary Management
C Monneret
Among the 35 new molecular entities approved by the FDA in 2011, 17 were particularly notable for their significant contributions to the health of patients, including abiraterone acetate, vandetanib, belatacept and fidaxomicin. Thus, abiraterone acetate, namely Zytiga®, was included as the first in a new class of drugs to treat late-stage prostate cancer. The ability of Zytiga® to prolong survival in these patients was considered as significant because they have few other treatments options and the benefits of Zytiga® outweighed the risks of reported side-effects...
March 2013: Annales Pharmaceutiques Françaises
B Sautois, C Gennigens
Docetaxel chemotherapy is a standard treatment for fit men with symptomatic castration-resistant prostate cancer. Unfortunately docetaxel resistant disease will systematically develop and second-line treatment may be appropriate. Until recently no standard treatment was approved in this setting and mitoxantrone was commonly used. Three new drugs have shown benefit in randomised phase 3 multicenter clinical trials published since 2010. Cabazitaxel, abiraterone and enzalutamide were shown to prolong overall survival of men with metastatic castration-resistant prostate cancer previously treated with chemotherapy...
February 2013: Revue Médicale de Liège
Robert J Cersosimo
OBJECTIVE: To review the activity of 3 new agents approved for the management of advanced castration-resistant prostate cancer (CRPC): sipuleucel-T, cabazitaxel, and abiraterone acetate. DATA SOURCES: Literature was accessed through MEDLINE (1977-June 2012) and abstracts from the American Society of Clinical Oncology (2000-2012) using the terms castration-resistant and hormone-refractory prostate cancer, sipuleucel-T, cabazitaxel, abiraterone, Provenge, Jevtana, and Zytiga...
November 2012: Annals of Pharmacotherapy
Bengt Jönsson, Nils Wilking
Public payment is key to market access for new therapeutics including cancer vaccines and cancer immunotherapeutics. However, the methodology for economic evaluation aimed at informing decisions about pricing and reimbursement is different for cancer vaccines, such as HPV for preventing the occurrence or incidence of cancer, and immunotherapeutics for treatment of patients with manifest cancer. Vaccination against HPV is a traditional public health intervention, where the role of economic evaluation is to inform decisions about optimal vaccination strategies...
September 2012: Human Vaccines & Immunotherapeutics
Charles E Myers, Gargi Basu, Brian Wright, Joanne Mahanes, Anthony Spinelli
After Taxotere fails, treatment options for metastatic prostate cancer are limited. The three drugs with FDA approval in this setting, Jevtana, Provenge and Zytiga, are associated with median survivals of less than 2 years. In part, the impact on survival is the result of low response rates, indicating a significant proportion of patients exhibiting de novo resistance to these agents. An alternate approach is to let treatment selection be governed by gene expression profiling so that the treatment is tailored to the specific patient...
January 2012: Case Reports in Oncology
E David Crawford, Thomas W Flaig
The rapid approval of several novel agents has given prostate cancer patients and their treating physicians many new and effective therapeutic options. Three new medical therapies were recently approved on the basis of prolonged overall survival in castration-resistant prostate cancer patients: sipuleucel-T (Provenge), cabazitaxel (Jevtana), and abiraterone acetate (Zytiga). Additionally, there are several other promising prostate cancer agents in late-stage development, including MDV3100, PROSTVAC-VF (Prostvac), orteronel (TAK-700), and radium-223 chloride (Alpharadin), each with a novel mechanism of action...
January 2012: Oncology (Williston Park, NY)
Lesley J Scott, Lily P H Yang, Katherine A Lyseng-Williamson
Oral abiraterone acetate (Zytiga®), a selective cytochrome P450 17A1 enzyme inhibitor, is used in combination with prednisone or prednisolone to treat patients with metastatic castration-resistant prostate cancer (CRPC) who have previously received docetaxel-containing chemotherapy. In a clinical trial in patients with CRPC, abiraterone acetate plus prednisone significantly prolonged overall survival, the time to prostate-specific antigen progression and progression-free survival compared with placebo plus prednisone...
March 1, 2012: Drugs & Aging
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