Submit safety and efficacy data: CDSCO panel Tells Zydus on Anticancer Drug Relugolix
New Delhi: In response to the drug major Zydus's proposal for the manufacture and marketing of the drug Relugolix 120 mg tablets, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to present the safety and efficacy data of the anticancer drug Relugolix (innovator).
This came after the drug major Zydus presented its proposal for the manufacture and marketing of the drug Relugolix 120 mg tablets indicated for the treatment of adult patients with advanced prostate cancer along with bioequivalence (BE) study report and justification for the local clinical trial waiver.
Innovator Drug refers to a drug that receives a patent on its chemical formulation or manufacturing process, obtains approval from the FDA or any regulatory authority after extensive testing, and is sold under a brand name.
Relugolix is a gonadotropin-releasing hormone (GnRH) receptor antagonist used in the treatment of several hormone-responsive conditions. It was first approved in Japan in 2019, under the brand name Relumina, for the symptomatic treatment of uterine fibroids, and more recently by the United States FDA in 2020, under the brand name Orgovyx, for the treatment of advanced prostate cancer. This branded product was later approved by the European Commission on April 29, 2022. Relugolix has also been studied in the symptomatic treatment of endometriosis.
Relugolix is an oral GnRH receptor antagonist for androgen deprivation therapy in the treatment of advanced prostate cancer. Relugolix is indicated for the treatment of adult patients with advanced prostate cancer. In a combination product with estradiol and norethindrone, relugolix is indicated for the once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
The mechanism of action of relugolix is as a Gonadotropin-Releasing Hormone Receptor Antagonist, Cytochrome P450 3A Inducer, Cytochrome P450 2B6 Inducer, and Breast Cancer Resistance Protein Inhibitor, P-Glycoprotein Inhibitor. The physiologic effect of relugolix is by means of Decreased GnRH Secretion.
Earlier, Medical Dialogue Team had reported about the CDSCO Panel granted permission to drug major Zydus to conduct the BE study for the anticancer drug Relugolix.
At the SEC meeting for Oncology and Hematology held on the 30th May 2023, the expert panel reviewed the proposal presented by the drug major Zydus for manufacturing and marketing the anticancer drug Relugolix 120 mg tablets indicated for the treatment of adult patients with advanced prostate cancer along with BE study report and justification for the local clinical trial waiver.
After detailed deliberation, the committee recommended that the firm should present the innovator’s safety and efficacy data for further consideration.
