Myovant's Orgovyx (relugolix) Receives the US FDA's Approval as the First Oral GnRH Receptor Antagonist for Advanced Prostate Cancer
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
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