Posted by Michael Wonder on 23 Jun 2020
Myovant Sciences announces priority review and FDA acceptance of new drug application for once daily, oral relugolix for advanced prostate cancer
22 June 2020 - Priority review status expected to accelerate review, with a target FDA action date of 20 December 2020
Myovant Sciences today announced that its new drug application for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer has been accepted for Priority Review by the U.S. FDA.
Myovant’s Phase 3 clinical program for advanced prostate cancer consisted of a randomised, open-label, parallel-group, multinational clinical study designed to evaluate the safety and efficacy of relugolix in over 900 men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy.
