Regulatory Focus™ > News Articles > 2019 > 7 > FDA Drafts Guidance on Developing GnRH Analogues to Treat Advanced Prostate Cancer

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Posted 17 July 2019 | By Zachary Brennan 

FDA Drafts Guidance on Developing GnRH Analogues to Treat Advanced Prostate Cancer

The US Food and Drug Administration (FDA) on Wednesday released draft guidance to help sponsors establish the effectiveness and safety of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer.
GnRH agonists and antagonists are a mainstay for treating patients with prostate cancer, FDA says, noting that it is one of the most common forms of cancer in American men.
“New drug applications for GnRH analogues typically rely, in part, on FDA’s finding of safety and/or effectiveness for a previously approved GnRH analogue and are submitted through the pathway described by section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act,” the 10-page draft says.
In trying to provide industry with the most current information available for developing GnRH analogues, the bulk of the draft focuses on Phase 3 efficacy trial considerations, with subsections on trial design, trial population, dose selection, trial procedures and timing of assessments, pharmacokinetics and pharmacodynamics, efficacy endpoints and statistical considerations.
“Sponsors should conduct single-arm trials using T [testosterone] levels as surrogate endpoints to support the approval of GnRH analogues. These trials should demonstrate the following:
  • Attainment of a castrate
  • Maintenance of castrate T levels until the end of a dosing interval
  • Maintenance of castrate T levels immediately after later doses (not the first dose) of the study drug.”
Other sections deal with nonclinical development and labeling considerations.

The draft also includes an appendix on the in vitro drug-release method development, acceptance criteria and data submission that should be provided in a new drug application.
Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues: Draft Guidance for Industry


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