Shots:

• The approval is based on a P-III HERO study assessing Relugolix (360mg loading dose followed by 120mg- qd) vs leuprolide acetate (3mos. depot injection) in patients with advanced prostate cancer. The therapy is expected to be available in Jan’2021
• Results: met its 1EPs- sustained testosterone suppression to castrate levels (< 50 ng/dL) @48wks. (96.7% vs 88.8%).
• 2EPs include @day4 & 15 suppression of testosterone to castrate levels (56% & 99% vs 0% & 12%); profound suppression of testosterone (< 20 ng/dL) @day15 (78% vs 1%); reduction in PSA by 65% @day15 and by 83% @day 29

 ­ Ref: GlobeNewswire | Image: Myovant