Myovant Sciences submits NDA to the FDA for once-daily, oral relugolix for the treatment of men with advanced prostate cancer.

Myovant Sciences announced that it has submitted a New Drug Application (NDA) to the FDA for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer. Myovant also announced that it expects to submit its NDA for once-daily, oral relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for women with heavy menstrual bleeding associated with uterine fibroids in May 2020.

The NDA submission is supported by positive results from the Phase III HERO study, a randomized pivotal study comparing relugolix versus leuprolide acetate. Relugolix met the primary efficacy endpoint with 96.7% of men achieving sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks. Six key secondary endpoints demonstrated superiority to leuprolide acetate, including sustained testosterone suppression to castrate levels through 48 weeks, rapid suppression of testosterone at Day 4 and at Day 15, profound suppression of testosterone (< 20 ng/dL) at Day 15, rapid suppression of prostate-specific antigen (PSA) at Day 15, and suppression of follicle-stimulating hormone (FSH) at Week 24 (all p-values < 0.0001).

The overall incidence of adverse events in the relugolix and leuprolide acetate groups was comparable (92.9% vs. 93.5%, respectively). Major adverse cardiovascular events were reported in 2.9% of men in the relugolix group versus 6.2% of men in the leuprolide acetate group. These events included non-fatal myocardial infarction, non-fatal stroke, and all-cause mortality..