US FDA grants approval of Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer

Approval was based on the open-label Phase III HERO study (n=930) which reported superior suppression of testosterone levels to castrate levels through 48 weeks with relugolix vs leuprolide (96.7% v 88.8%; P<0.001 for superiority).

Source:

FDA