TerSera has obtained Health Canada’s approval for a supplemental new drug submission for ZOLADEX LA (goserelin acetate) 10.8mg administered every 12 weeks to manage oestrogen receptor-positive (ER+) early breast cancer.
The new dosing option of ZOLADEX is aimed at pre and perimenopausal women with an increased recurrence or advanced breast cancer risk.
Since 1995, a monthly dose of ZOLADEX 3.6mg has been approved for breast cancer treatment.
The latest approval provides a three-month dosing alternative specifically for younger women with hormone-positive (HR+) breast cancer.
The approval of the 10.8mg dosage is supported by multiple international studies that assessed the efficacy and safety of goserelin for ovarian function suppression in premenopausal patients with HR+ breast cancer.
ZOLADEX LA is now approved for breast cancer treatment in 60 countries, with additional regulatory reviews in progress.
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It is also used to treat prostate cancer and specific benign gynaecological disorders.
ZOLADEX is an injectable luteinising hormone-releasing hormone agonist (LHRHa) currently available in 125 countries.
It was first approved in Canada in 1989 and comes as a 3.6mg implant for 28-day dosing or as a 10.8mg implant for dosing every 12 weeks.
TerSera chief medical officer Nancy Martin stated: “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.”
In February 2017, TerSera signed an agreement with AstraZeneca to obtain the commercial rights to Zoladex in the US and Canada.
