US: FDA drafts guidance on developing GnRH analogues to treat advanced prostate cancer

18-07-2019

US: FDA drafts guidance on developing GnRH analogues to treat advanced prostate cancer

(Source: RAPS 2019-07-19)

The US Food and Drug Administration (FDA) on Wednesday released draft guidance to help sponsors establish the effectiveness and safety of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer.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.

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