Sun Pharma Industries Gets CDSCO Panel Nod to assess safety and efficacy of Relugolix Tablets for advanced prostate cancer

New Delhi: In order to assess the safety and efficacy of Relugolix Tablets 120 mg indicated for the treatment of advanced prostate cancer, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has given its nod to the drug major Sun Pharmaceutical Industries for conducting the Phase-IV clinical trial.

This came after Sun Pharmaceutical Industries presented their Phase-IV clinical trial protocol to assess the safety and efficacy of Relugolix Tablets 120 mg indicated for the treatment of advanced prostate cancer as per the condition of manufacture and marketing permission granted by this office.

Relugolix is an oral GnRH receptor antagonist for androgen deprivation therapy in the treatment of advanced prostate cancer.

The pathogenesis and progression of prostate cancer appear to be driven, at least in part, by the effects of testosterone. Androgen deprivation has been demonstrated to result in cell death and tumor regression in many well-differentiated prostate cancer cell lines; for this reason, androgen deprivation therapy (ADT) has become a standard in the treatment of prostate cancer, particularly in advanced disease.

Testosterone production in males is carried out in the Leydig cells of the testes and is stimulated by luteinizing hormone (LH), which itself is produced in the pituitary gland following the binding of gonadotropin-releasing hormone (GnRH) to corresponding GnRH receptors. Relugolix is a competitive antagonist of these GnRH receptors, thereby decreasing the release of LH and, ultimately, testosterone.