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is a trademark of Sumitomo Pharma Co., Ltd., used under license.SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license.SUMITOMO is a registered trademark of Sumitomo Chemical Co., Ltd., used under license.ORGOVYX%u00ae and its associated logo are registered trademarks of Sumitomo Pharma Switzerland GmbH.ADT: androgen-deprivation therapy; P-gp: P-glycoprotein; ECG: electrocardiogram; GnRH: gonadotropin-releasing hormone*Comparative clinical signifi cance has not been established.%u2020 HERO: A Phase 3, multinational, randomized, open-label, parallel-group study comparing ORGOVYX%u00ae (n=622) to leuprolide (n=308) in adult men with androgen-sensitive advanced prostate cancer requiring at least 1 year of ADT. Patients were randomized 2:1 to receive ORGOVYX%u00ae (120%u00a0mg once daily after a single oral loading dose of 360%u00a0mg) or leuprolide acetate (22.5%u00a0mg [or 11.25%u00a0mg in Japan or Taiwan]) injection subcutaneously every 3 months. Leuprolide acetate 11.25%u00a0mg is a dosage regimen that is not recommended for this indication in Canada. The primary effi cacy outcome measure was medical castration rate, defi ned as achieving and maintaining serum testosterone suppression to castrate levels (<%u00a01.7 nmol/L) by Day%u00a029 through 48%u00a0weeks of treatment.3References: 1. Data on fi le - First and only. Sumitomo Pharma Canada, Inc. December 6, 2023. 2. ORGOVYX%u00ae Product Monograph. Sumitomo Pharma Switzerland GmbH. October 30, 2023. 3. Shore ND et al. Oral relugolix for androgen-deprivation therapy in advanced prostate cancer. N Engl J Med. 2020;382(32):2187%u20132196.Clinical use:Safety and effi cacy have not been established in pediatrics (<%u00a018 years of age).Most serious warnings and precautions:%u2022 QT prolongationRelevant warnings and precautions:%u2022 Co-administration with an oral P-gp inhibitor or a combined P-gp and strong cytochrome P450 (CYP) 3A inducer%u2022 ADT can prolong the QT interval %u2022 Therapy results in suppression of the pituitary gonadal system%u2022 Tests of pituitary gonadotropic and gonadal functions conducted during and after therapy may be affected%u2022 Monitor prostate-specifi c antigen (PSA) levels; if PSA increases, measure serum testosterone concentrations%u2022 Consider periodic monitoring of ECG and serum electrolyte levels for those at risk for QTc prolongation and electrolyte abnormality%u2022 Risk of decreased bone density with use of GnRH receptor agonist or antagonist%u2022 Men and women of reproductive potential should use contraception during treatment and for 2%u00a0weeks after the last dose%u2022 May impair fertility in males of reproductive potentialFor more information:Consult the Product Monograph at https://www.ca.sumitomo-pharma.com/assets/fi les/monographs/orgovyx.pdf for important information relating to adverse reactions, drug interactions, and dosing that has not been discussed in this piece. The Product Monograph is also available by calling 1-866-260-6291.THE FIRST AND ONLY ORAL ADT INDICATED IN ADVANCED PROSTATE CANCER*,1EFFICACY DATA FROM THE OPEN-LABEL HERO STUDYMedical castration rate (defi ned as achieving and maintaining testosterone suppression < 1.7 nmol/L) from Day 29 through Week%u00a048 (primary endpoint)%u2020,2%u2022 ORGOVYX%u00ae: 96.7% (95% CI: 94.9%, 97.9%)%u2022 Leuprolide: 88.8% (95% CI: 84.6%, 91.8%)Cumulative probability of testosterone suppression on Day 15 (secondary endpoints)%u2020%u2022 < 1.7 nmol/L: 98.7% of ORGOVYX%u00ae patients vs. 12.1% of leuprolide patients%u2022 < 0.7 nmol/L: 78.4% of ORGOVYX%u00ae patients vs. 1.0% of leuprolide patientsVISIT ORGOVYX.CAFOR MORE INFORMATION!%u00a9 2025 Sumitomo Pharma Canada, Inc. All rights reserved. RGX-CA-00004-23DIVEINTO THEORGOVYX%u00aeDATAORGOVYX%u00ae (relugolix tablets, 120%u00a0mg) is indicated for the treatment of adult patients with advanced prostate cancer.2fifffifffflfl%u001a%u0019%u0018%u0017%u0016%u0015%u0019%u0014