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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
·
BioSpace
上市批准
临床3期
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.
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机构
University of British Columbia
TerSera Therapeutics LLC
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