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FDA Approval of Prostate Cancer Treatments

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Drug Management of Prostate Cancer

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Abstract

The United States Food and Drug Administration has approved more than ten drugs for the treatment of prostate cancer, which include hormonal, supportive, and cytotoxic agents. Although these drugs have remarkably improved the management of patients with the disease, new treatments are greatly needed for achieving better clinical outcomes. Regulatory evaluation of newer agents under development is highly challenging, especially for agents intended for patients with advanced metastatic disease resistant to castration and/or docetaxel. Substantial evidence of efficacy and safety must be demonstrated for an agent to receive marketing approval. The evidence must be based on adequate, well-designed, and well-conducted clinical trials that provide quantitative assessments of measured clinical benefits and risks of the agent. Although improvements in survival and/or patient-reported outcomes continue to be valid endpoints for approving new claims or agents, effective surrogates that can reliably measure and predict clinical benefit remain to be established for accelerating drug development for the disease. Furthermore, appropriate utilization of trial results is very important. Subgroup analysis and/or post-hoc analysis results are not acceptable for regulatory action in general. Productive collaboration between all stakeholders and the agency is one of the keys for successful development of prostate cancer treatments.

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Notes

  1. 1.

    CRPC denotes the progressive recurrent disease setting of prostate cancer despite the low plasma levels of testosterone (<50 ng/dL) achieved by medical or surgical castration, a clinical phenomenon that is historically defined as androgen-independent or hormone-refractory prostate cancer. CRPC becomes well accepted now in that it is more conceptually appropriate than the other terms in reflecting the nature of the disease setting. Therefore, CRPC will be used in the review wherever a description of the disease setting is needed.

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Authors and Affiliations

  1. Office of Oncology Drug Products, The U.S. Food and Drug Administration, Silver Spring, MD, USA

    Yang-Min Ning

Authors
  1. Yang-Min Ning
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  2. Ramzi N. Dagher
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  3. Richard Pazdur
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Correspondence to Yang-Min Ning .

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Editors and Affiliations

  1. Medical Oncology Branch, NIH National Cancer Institute, Rockville Pike 9000, Bethesda, 20892, Maryland, USA

    William D. Figg

  2. Medical Oncology Branch, NIH National Cancer Institute, Rockville Pike 9000, Bethesda, 20892, Maryland, USA

    Cindy H. Chau

  3. School of Medicine, Dept. Urology, University of California, San Francisco, Divisadero Street 1600, San Francisco, 94115, California, USA

    Eric J. Small

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Ning, YM., Dagher, R.N., Pazdur, R. (2010). FDA Approval of Prostate Cancer Treatments. In: Figg, W., Chau, C., Small, E. (eds) Drug Management of Prostate Cancer. Springer, New York, NY. https://doi.org/10.1007/978-1-60327-829-4_35

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  • DOI: https://doi.org/10.1007/978-1-60327-829-4_35

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  • Print ISBN: 978-1-60327-831-7

  • Online ISBN: 978-1-60327-829-4

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