BRIEF—New guidance on GnRH analogues for prostate cancer

The US Food and Drug Administration (FDA) has published draft guidance offering recommendations for drug development programs to establish the effectiveness and safety of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer.

This guidance outlines standardizing trial design including information regarding patient population, endpoints, chemistry, manufacturing and statistical considerations. Regulatory requirements for approval of GnRH analogues are also covered.

The FDA is seeking comments and suggestions on the draft guidance.