Gonadotropin-Releasing Hormone Analogues Guidance

FDA has issued a draft guidance, Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues, with the agency’s current recommendations for an overall development program to establish the effectiveness and safety of gonadotropin-releasing hormone analogues for treating advanced prostate cancer. The document says that new drug applications for the analogues typically rely, in part, on an agency finding of safety and/or effectiveness for a previously approved analogue. They are submitted through the 505(b)(2) pathway. The guidance addresses the current regulatory requirements for approval of the agents and the use of a standardized approach to trial design.

Contents of the guidance are Introduction, Background, Development Program (product development, nonclinical development, phase 3 efficacy trial considerations, and labeling considerations), and Appendix.