TORONTO, April 24, 2024 /CNW/ - FORUS Therapeutics Inc. ("FORUS") is deeply disappointed and disagrees with the recent decision by the Honourable Christian Dubé, Minister of Health and Social Services in Quebec to deny listing XPOVIO^® (selinexor) in combination with VELCADE^® (bortezomib) and dexamethasone (XVd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy. This decision was based on a narrow and flawed interpretation of the data, resulting in a negative recommendation by the Institut national d'excellence en santé et en services sociaux (INESSS), the drug reimbursement agency in Quebec.

FORUS stands by its submission that the clinical issues related to the therapeutic value of XPOVIO were identified and addressed in the submission to INESSS.  This negative recommendation is entirely inconsistent with expert physician input and the identified needs of MM patients who have limited treatment options.  For all MM patients, the course of their disease involves several periods of remission and relapse until resistance develops to available therapies. It is therefore critical that patients have access to newer therapies like XPOVIO to optimize disease management.

Despite Health Canada approval, a positive CADTH decision, public reimbursement across all other Canadian provinces and positive funding recommendations from global jurisdictions such as Australia's Pharmaceutical Benefits Advisory Committee (PBAC) and Britain's National Institute for Health and Care Excellence (NICE) draft guidance, the Minister has refused to publicly fund XVd in Quebec.

"This denial of public reimbursement by Minister Dubé, raises many concerning questions and most importantly isolates the Quebec patient and treatment community," said Kevin Leshuk, President and CEO of FORUS. "This "postal code lottery" of access at play in our country continues to drive health disparities. At this time, we respectfully request to meet with Minister Dubé, to find a path forward that supports the Quebec Myeloma patient community, ensuring alignment within Canada and the rest of the world. We must find consistent solutions, do better as a country and provide fair and equitable access to treatments for all Canadian patients wherever they live."

Multiple myeloma (MM), commonly referred to as myeloma, is a blood cancer that is associated with the abnormal behavior and uncontrolled growth of a type of white blood cell – the plasma cell.

In Canada, it is estimated that in 2022 approximately 4,000 people will be diagnosed with multiple myeloma, and almost 12,500 Canadians are living with MM at any given time. 

Despite recent introductions of newer, effective treatments, MM remains an incurable, deadly disease with an estimated 5-year net survival rate of 50%. These facts reinforce the continued need for new treatments that can contribute to controlling the disease and extend patient benefits.   

XPOVIO is the first and only oral XPO1 inhibitor available for the treatment of multiple myeloma.  Its unique mechanism acts by blocking the nuclear export protein XPO1 which can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins.  Due to this novel mechanism of action, XPOVIO is being evaluated for use in multiple combination regimens. Health Canada approval was based on the Phase 3 BOSTON trial of XPOVIO in combination with once-weekly bortezomib and low-dose dexamethasone compared to twice-weekly bortezomib and low-dose dexamethasone in patients with relapsed or refractory multiple myeloma. The product monograph is available here.

XPOVIO^® is a registered trademark of Karyopharm Therapeutics Inc. and is used by FORUS Therapeutics Inc. under license.

FORUS Therapeutics is a Canadian biopharmaceutical company dedicated to advancing differentiated, novel medicines for hematologic malignancies and other forms of cancer. Our mission is to bring solutions to cancer patients, caregivers, physicians and our partners by accelerating unique and important treatments that meaningfully enhance life. For more information, visit: forustherapeutics.com

SOURCE FORUS Therapeutics

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