The sNDA approval of Zoladex LA 10.8mg introduces a three-month dosing alternative for young women diagnosed with hormone-positive breast cancer
TerSera Canada secures Health Canada’s approval for Zoladex LA 10.8mg in ER+ breast cancer. (Credit: Sam Moghadam Khamseh on Unsplash)
TerSera Canada has received approval from Health Canada for Zoladex LA (goserelin acetate) to treat certain estrogen receptor-positive (ER+) early breast cancer patients.
Zoladex is an injectable luteinising hormone-releasing hormone agonist (LHRHa).
Health Canada has approved TerSera’s supplemental new drug submission (sNDA) to use Zoladex LA 10.8mg in ER+ early breast cancer patients with a high risk of women in pre- and perimenopausal phase with recurrence or advanced breast cancer.
The approval introduces a three-month dosing alternative for young women diagnosed with hormone-positive (HR+) breast cancer.
TerSera chief medical officer Nancy Martin said: “TerSera is committed to supporting the unique needs of young women with HR+ breast cancer.
“We are proud to bring this new three- month breast cancer dosing option for Zoladex to Canada.”
The sNDA approval is supported by results from various international clinical trials.
The studies assessed the safety and effectiveness of administering goserelin at 10.8mg every 12 weeks to suppress ovarian function in premenopausal patients diagnosed with HR+ breast cancer.
The sNDA approval in Canada follows the inclusion by the US National Comprehensive Cancer Network (NCCN) Breast Cancer Panel of both goserelin 3.6mg and 10.8mg, as methods for suppressing ovarian function.
Zoladex has approvals for the treatment of prostate cancer, breast cancer, and some benign gynaecological conditions. The drug is accessible in 125 nations.
Approved first in Canada in 1989, Zoladex is offered in a 3.6mg implant administered every 28 days and a 10.8mg implant administered every 12 weeks.
The monthly 3.6mg dose of Zoladex has been approved for breast cancer treatment since 1995.
Zoladex LA has received approval for breast cancer treatment in over 60 countries, with multiple additional regulatory evaluations currently in progress.
TerSera Canada is the Canadian division of TerSera Therapeutics, a US-based oncology and urology-focused biopharmaceutical company.
TerSera Therapeutics acquired the commercial rights to Zoladex in the US and Canada from AstraZeneca for $250m in 2017.