FDA Advanced Prostate Cancer Developing Gonadotropin-Releasing Hormone Analogues
标准简介
Advanced Prostate Cancer Developing Gonadotropin-Releasing Hormone Analogues[附网盘链接]由Food&Drug Administration于当前发布，适用于United States。标准截图
![Advanced Prostate Cancer Developing Gonadotropin-Releasing Hormone Analogues[附网盘链接]](/img/20210914103549jb99o.jpg)
标准文档说明
标准文档类型为Advanced Prostate Cancer Developing Gonadotropin-Releasing Hormone Analogues[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Draft — Not for Implementation 1 Advanced Prostate Cancer: Developing 2 Gonadotropin-Releasing Hormone Analogues 1
3 Guidance for Industry 4 5 6 7 8 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 9 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 10 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 11 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 12 for this guidance as listed on the title page. 13 14 15 16 17 I. INTRODUCTION 18 19 This guidance describes the Food and Drug Administration’s (FDA’s) current recommendations 20 regarding the overall development program to establish the effectiveness and safety of 21 gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer. 22 23 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 24 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 25 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 26 the word should in Agency guidances means that something is suggested or recommended, but 27 not required. 28 29 30 II. BACKGROUND 31 32 GnRH analogues, both agonists and antagonists, remain a mainstay for treating patients with 33 prostate cancer. Both are intended to reduce testosterone (T) levels in the blood, a major driver of 34 prostate cancer growth, but they have different properties. GnRH agonists cause a transient surge 35 in luteinizing hormone (LH) and testosterone. This surge desensitizes the LH receptors and is 36 followed by a sustained decrease in T levels. Patients whose LH receptors have not been fully 37 desensitized will develop a surge in testosterone during subsequent administration of a GnRH 38 agonist. This increase is referred to as the acute-on-chronic effect. GnRH antagonists bind to the 1
This guidance has been prepared by the Division of Oncology Products 1 in the Center for Drug Evaluation and Research at the Food and Drug Administration.
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