Health Canada Approves ZOLADEX® LA for the Management of Estrogen Receptor-Positive (ER+) Early Breast Cancer with a High Risk of Recurrence or Advanced Breast Cancer in Pre- and Perimenopausal Women

2024-05-07

MARKHAM, Ontario--(BUSINESS WIRE)-- TerSera Canada Inc. today announced that Health Canada has approved a supplemental New Drug Submission for ZOLADEX LA (goserelin acetate) 10.8mg every 12 weeks for the management of estrogen receptor-positive (ER+) early breast cancer with a high risk of recurrence or advanced breast cancer in pre- and perimenopausal women.1 While the monthly dose of ZOLADEX (3.6mg) has been approved for use in breast cancer2 since 1995, this recent approval provides a 3-month dosing option for young women with hormone-positive (HR+) breast cancer. “For young women with hormone sensitive breast cancer, suppression of ovarian function is a core component of their treatment plan to prevent recurrence,” said Nathalie LeVasseur, MD, FRCPC, Assistant Clinical Professor, Division of Medical Oncology at the University of British Columbia in Vancouver. “I am pleased to see ZOLADEX LA is now available as a 3-month dosing option for premenopausal women with ER+ breast cancer.” Every year, approximately 5,000 young Canadian women are diagnosed with breast cancer.3 Breast cancer is the leading cause of cancer death among women in Canada ages 30-49. According to a recent study, rates of breast cancer in women under the age of 50 are rising in Canada.4 “We are grateful that young women seeking treatment for breast cancer now have multiple dosing options available for the foundational treatments that they are relying on,” said Cathy Ammendolea, Chair of the Board of Directors for the Canadian Breast Cancer Network (CBCN). This approval is based on multiple international studies that have evaluated the safety and efficacy of goserelin 10.8 mg every 12 weeks for ovarian function suppression in premenopausal patients with HR+ breast cancer.5-8 Worldwide, ZOLADEX LA (goserelin acetate 10.8mg) is approved for use in breast cancer in over 60 countries, with multiple additional regulatory reviews underway. “TerSera is committed to supporting the unique needs of young women with HR+ breast cancer HR+ breast cancer,” said Nancy Martin, MD, PharmD, Chief Medical Officer at TerSera. “We are proud to bring this new 3-month breast cancer dosing option for ZOLADEX to Canada.” About ZOLADEX® (goserelin implant) ZOLADEX is an injectable luteinizing hormone-releasing hormone agonist (LHRHa) used to treat prostate cancer, breast cancer, and certain benign gynecological disorders. ZOLADEX is available in 125 countries worldwide. First approved in Canada in 1989, ZOLADEX is available as a 3.6 mg implant dosed every 28 days or as a 10.8 mg implant dosed every 12 weeks.1,2 For more information about ZOLADEX and ZOLADEX LA, access the Canadian Product Monographs here. About TerSera Canada Inc. TerSera Canada Inc. is the Canadian operations of TerSera Therapeutics LLC, a biopharmaceutical company with a focus in oncology and urology. Founded in 2016, TerSera is building new cornerstones of care through its portfolio of unique therapeutics, amplifying their ability to deliver meaningful outcomes for patients. For more information, please visit tersera.ca or follow us on LinkedIn. References ZOLADEX (goserelin implant) 10.8 mg product monograph. TerSera Therapeutics LLC. ZOLADEX (goserelin implant) 3.6 mg product monograph. TerSera Therapeutics LLC. Canadian Cancer Statistics. Canadian Cancer Society, 2023. Seely JM, Ellison LF, Billette J-M, Zhang SX, Wilkinson AN. Incidence of Breast Cancer in Younger Women: A Canadian Trend Analysis. Canadian Association of Radiologists Journal. 2024; 0(0). doi:10.1177/08465371241246422. Noguchi S, Kim HJ, Jesena A, et al. Phase 3, open-label, randomized study comparing 3-monthly with monthly goserelin in pre-menopausal women with estrogen receptor-positive advanced breast cancer estrogen receptor-positive advanced breast cancer. Breast Cancer. 2016; 23:771-779. Masuda N, Iwata H. Rai Y, et al. Monthly versus 3-monthly goserelin acetate treatment in pre-menopausal patients with estrogen receptor-positive early breast cancer estrogen receptor-positive early breast cancer. Breast Cancer Res Treat. 2011; 126:443-451. El Zawawy SF, Khedr G. 209P Efficacy and feasibility of long acting every three months goserelin for premenopausal breast cancer patients during COVID pandemic. Annals of Oncology. 2022;33: S631. Wu H, Bian L, Xie J, et al. 111P Goserelin 3 monthly depot is noninferior to goserelin monthly depot in the treatment of breast cancer: A real-world evidence study. ESMO Open. 2023;8(1):101335. ZOLADEX® is a registered trademark of AstraZeneca or its affiliates and is used herein under license. ©2024 TerSera Therapeutics LLC. All rights reserved.