CDE seeks feedback on clinical guidelines for GnRH agonists in advanced prostate cancer



The Center for Drug Evaluation (CDE) released a notification on clinical trial protocols for gonadotropin-releasing hormone (GnRH) agonists in advanced prostate cancer. The document highlights unique mechanisms and differences in clinical design and efficacy evaluation endpoints.

Primary endpoint: prostate cancer treatment is designed to suppress serum testosterone to the castration level, thereby arresting disease progression. Therefore, serum testosterone level is a direct and reliable efficacy evaluator.

Pharmacokinetics/pharmacodynamics: low-dose GnRH agonists can maintain the level of castration after down-regulation/desensitization of GnRH receptors, so pharmacokinetics and efficacy have a non-linear relationship.

Administration cycle: for formulations administered once a month, evaluate efficacy at least three or four times.

Enrolled population: some adverse reactions occur in early stage prostate cancer, so the enrollment of advanced cases is recommended.

Combination therapy: to maintain focus on the primary endpoint, estrogen, 5-α reductase inhibitors, CYP17 inhibitors and others are not recommended.

Safety information: for 30 days following administration, monitor for injection site reactions such as edema, pain, erythema, etc., as well as cardiovascular events, and possible adverse reactions such as bone pain and spinal cord compression in advanced patients.

Leuprorelin, goserelin and triptorelin are all approved GnRH agonists in China. Meanwhile, Hengrui Medicine’s GnRH receptor antagonist SHR7280 was approved for estrogen-dependent diseases in May 2020.

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