GSK's JEMPERLI (dostarlimab for injection) approved in Canada as an anti-PD-1 therapy for recurrent or advanced endometrial cancer
MISSISSAUGA, ON, Dec. 23, 2021 /CNW/ - GSK announces today that it has been granted Notice of Compliance with conditions for its endometrial cancer treatment JEMPERLI (dostarlimab for injection) by Health Canada.
As an anti-PD-1 therapy for recurrent or advanced endometrial cancer approved in Canada, JEMPERLI is indicated as a monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer, that has progressed on or following prior treatment with a platinum containing regimen.
"Canadian women with recurrent endometrial cancer, or advanced disease that has progressed on or after chemotherapy, currently have few options for treatment and face a poor prognosis," said Marni Freeman, Country Medical Director at GSK Canada. "This critical approval has the potential to noticeably improve the treatment landscape for these women and demonstrates GSK's continued commitment to fill an unmet need of patients with gynaecologic cancers."
"Women with endometrial cancer have few therapeutic options. We at the Society of Gynecologic Oncology of Canada (GOC) welcome any approval that paves the way for women with endometrial cancer to access immunotherapy as part of their standard of care therapeutic options" expressed Dr. Helen MacKay, President, The Society of Gynecologic Oncology of Canada and Head, Division of Medical Oncology & Hematology, Sunnybrook Odette Cancer Centre.
About endometrial cancer
Endometrial cancer is the most common gynecologic cancer in Canada. The disease is found in the inner lining of the uterus, known as the endometrium, and represents 95% of all uterine cancers. It is estimated that 7,600 Canadian women will be diagnosed with endometrial cancer and 1,235 will die of the disease in 2021.
There are limited treatment options for women whose disease progresses on or after first-line therapy. Approximately 25% of women with endometrial cancer will be diagnosed with advanced disease and 20% will have a recurrence of the disease. The 5-year overall survival is estimated to be 83%, however is below 20% for those with metastatic disease, thus research and new treatment availability is of utmost importance.
About JEMPERLI (dostarlimab for injection)
JEMPERLI (dostarlimab for injection) is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum containing regimen.
JEMPERLI is an anti-programmed death receptor-1 (PD-1) antibody that binds to the PD-1 receptor and blocks its interaction with the ligands PD-L1 and PD-L2. This conditional approval of JEMPERLI is based on results from the multi-cohort GARNET study. In addition to GARNET, JEMPERLI is being investigated as monotherapy and as part of combination regimens for women with recurrent or primary advanced endometrial cancer, stage III or IV non-mucinous epithelial ovarian cancer, and for patients with advanced solid tumours or metastatic cancer.
Please consult the Product Monograph at www.gsk.ca for complete safety information. The Product Monograph is also available by calling 1-800-387-7374.
About GOC
The Society of Gynecologic Oncology of Canada is a non-profit organization consisting of physicians, nurses, scientists, and other health care professionals specializing in gynecologic oncology. Its purpose is to improve the care of women with or at risk of gynecologic cancer by raising standards of practice, encouraging ongoing research, promoting innovation in prevention, care and discovery, and advancing awareness. GOC also seeks to disseminate knowledge to practitioners, patients and the public on gynecologic cancer as well as cooperate with other organizations committed to women's health care, oncology, and related fields. Learn more about us by visiting our website at gyneoncology.ca.
About GSK
GSK is a science-led global healthcare company. For further information please visit www.gsk.ca.
SOURCE GlaxoSmithKline Inc.
And GSK Enquiries: +1 905-819-3363 (English Media Line), +1 450-680-4812 (French Media Line)
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