Health Canada Approves ZOLADEX® LA for High-Risk ER+ Early or Advanced Breast Cancer in Pre- and Perimenopausal Women

TerSera Canada Inc. has announced that Health Canada has approved a new dosing schedule for ZOLADEX LA (goserelin acetate), allowing a 10.8 mg dose every 12 weeks for the management of estrogen receptor-positive (ER+) early breast cancer that is at high risk of recurrence, as well as advanced breast cancer in premenopausal and perimenopausal women. Previously, the monthly dose of ZOLADEX (3.6 mg) had been approved for breast cancer treatment since 1995. This new approval offers a 3-month dosing option for young women with hormone receptor-positive (HR+) breast cancer.

Dr. Nathalie LeVasseur, Assistant Clinical Professor in the Division of Medical Oncology at the University of British Columbia, expressed her approval of this development. She highlighted the importance of ovarian function suppression in the treatment plans for young women with hormone-sensitive breast cancer to prevent recurrence. Dr. LeVasseur believes that the availability of a 3-month dosing option is a significant advancement for premenopausal women with ER+ breast cancer.

Breast cancer remains a critical health issue in Canada, especially among younger women. Annually, around 5,000 young Canadian women are diagnosed with the disease, which is the leading cause of cancer death in women aged 30-49. Research indicates that breast cancer rates among women under 50 are on the rise in Canada.

Cathy Ammendolea, Chair of the Board of Directors for the Canadian Breast Cancer Network (CBCN), expressed gratitude for the new dosing options. She emphasized that having multiple dosing schedules available is crucial for the foundational treatments that young women with breast cancer rely on.

The approval of the 10.8 mg every 12 weeks dosing schedule is based on several international studies that assessed the safety and efficacy of goserelin for ovarian function suppression in premenopausal patients with HR+ breast cancer. ZOLADEX LA is already approved for breast cancer treatment in over 60 countries, and additional regulatory reviews are in progress.

Dr. Nancy Martin, Chief Medical Officer at TerSera, stated the company's commitment to addressing the unique needs of young women with HR+ breast cancer. She expressed pride in making this new 3-month dosing option available in Canada.

ZOLADEX is an injectable luteinizing hormone-releasing hormone agonist (LHRHa) used to treat not only breast cancer but also prostate cancer and certain benign gynecological disorders. It is available in over 125 countries. In Canada, ZOLADEX was first approved in 1989 and is available either as a 3.6 mg implant administered every 28 days or as a 10.8 mg implant administered every 12 weeks.

TerSera Canada Inc. operates under TerSera Therapeutics LLC, a biopharmaceutical company focused on oncology and urology. Founded in 2016, TerSera is dedicated to building new treatments that offer meaningful outcomes for patients.

This approval marks a significant step forward in the treatment options available for young women battling HR+ breast cancer in Canada. The new 3-month dosing option provides more flexibility and convenience, potentially improving adherence to treatment plans and overall patient outcomes.