Shots:

• The EC has approved the MAA for Orgovyx (120mg) to treat advanced hormone-sensitive prostate cancer in adult patients
• The approval was based on the P-III (HERO) study to evaluate the safety & efficacy of relugolix vs leuprolide in ~1,000 men with androgen-sensitive advanced prostate cancer who required 1yr. of continuous androgen deprivation therapy
• The trial met the 1EPs & 2EPs and achieved sustained testosterone suppression to castrate levels (<50 ng/dL) @48wks in 96.7% vs 88.8%, suppression of testosterone to castrate levels (56% vs 0% and 99% vs 12%) @Day 4 & 15, profound suppression of testosterone (<20 ng/dL) @Day 15 (78% vs 1%). The approval is valid in all 27 EU member states, Iceland, Norway & Liechtenstein

Ref: Myovant | Image: Myovant