Health Canada has approved a new indication for GSK’s Jemperli (dostarlimab for injection) in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer who are candidates for systemic therapy, based on Part 1 of the pivotal RUBY study.
“Today’s approval supports our ambition for Jemperli to advance the standard of care for Canadian adult patients with primary advanced or recurrent dMMR/MSI-H endometrial cancer,” said Marni Freeman, Country Medical Director at GSK Canada. “This expanded approval of Jemperli offers a new care option to healthcare professionals treating this patient population with high unmet need.”
In December 2021, Jemperli had previously been granted Notice of Compliance with conditions by Health Canada as a monotherapy for the treatment of adult patients with dMMR or MSI-H recurrent or advanced endometrial cancer, that has progressed on or following prior treatment with a platinum containing regimen.
“The Society of Gynecologic Oncology of Canada (GOC) proudly supports the inclusion of medications like dostarlimab, recognizing their potential to provide patients with valuable choices, prolong survival, and ultimately benefit women battling cancer,” expressed Dr. Alon Altman, President, The Society of Gynecologic Oncology of Canada. “We believe in the importance of a diverse and comprehensive approach to treatment, and we commend the efforts of all involved in advancing innovative solutions for women’s health. Our organization remains committed to advocating for initiatives that enhance the well-being of women affected by gynecologic cancers.”
The new indication for Jemperli was approved by Health Canada following review under Health Canada’s Priority Review policy and the Project Orbis framework of the US Food and Drug Administration (FDA) Oncology Center of Excellence, which is an international partnership designed to give cancer patients faster access to promising cancer treatments, allowing concurrent submission to and review among regulatory authorities in the US, Australia, Canada, Switzerland, Singapore and United Kingdom.
“Endometrial cancer is the most common gynecologic cancer in Canada, and there have been limited new treatment options for patients over the past few decades,” said Jackie Manthorne, President and CEO of the Canadian Cancer Survivor Network (CCSN). “The CCSN is pleased to see a newly approved innovative treatment option for patients in Canada. We hope that new treatments like dostarlimab will not be delayed by our Canadian reimbursement and funding systems. Patients shouldn’t have to wait, because cancer certainly can’t wait!”
The new expanded approval in Canada is supported by interim analysis results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial. The RUBY trial data were presented at the European Society for Medical Oncology (ESMO) Virtual Plenary and Society of Gynecologic Oncology (SGO) Annual Meeting on March 27, 2023, and were simultaneously published in The New England Journal of Medicine.