On June 7, 2022 FORUS Therapeutics Inc ("FORUS"), reported that on May 31, 2022 XPOVIO (selinexor) was authorized for sale by Health Canada in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy (Press release, FORUS Therapeutics, JUN 7, 2022, View Source;utm_medium=rss&utm_campaign=forus-therapeutics-inc-forus-announces-xpovio-selinexor-is-authorized-for-sale-by-health-canada [SID1234615698]).
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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.
This is the first regulatory approval for XPOVIO in Canada in multiple myeloma and follows recent approvals in Australia, China, South Korea, Singapore and the United States.
XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound.
"The FORUS team is very proud to launch XPOVIO in Canada and bring forth a novel and effective addition to existing regimens for the treatment of relapsed or refractory multiple myeloma. This first approval is just the beginning of our journey to fulfill our company’s mission and vision. We are moving quickly to ensure Canadian MM patients have broad, equitable access to XPOVIO." said Kevin Leshuk, President and CEO of FORUS.
"The approval of XPOVIO brings an exciting new anti-myeloma agent with a novel mechanism of action into the treatment armamentarium for relapsed multiple myeloma," says Dr. Donna Reece, Professor and Director of the Program for Multiple Myeloma and Related Diseases in the Department of Medical Oncology and Hematology at Princess Margaret Cancer Centre/University of Toronto, Chief Medical Officer and Director of the Canadian Myeloma Research Group (CMRG). "Treating multiple myeloma is not a one-size-fits-all approach and the approval of XPOVIO in combination with bortezomib and dexamethasone will allow clinicians to further tailor their treatment strategies to meet the unique needs of each individual patient. In addition, the CMRG and Canadian patients played a significant role in the clinical development of XPOVIO, and it is rewarding to see these efforts result in a Health Canada approval."
About Multiple Myeloma
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. Plasma cells are made in the bone marrow – the spongy tissue found inside bones – and are an important component of the body’s immune system because they produce antibodies. In myeloma, abnormal plasma cells (also known as myeloma cells) interfere with the production of normal healthy blood cells in the bone marrow and overproduce inactive clones of abnormal antibodies that can negatively affect different parts of the body such as the bones and kidneys. The cause or causes of myeloma remain unknown.
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.
Martine Elias, MSc, Executive Director, Myeloma Canada states "New treatment options for the Myeloma patient community are incredibly important as this disease remains incurable and each patient has very unique needs due to the disease and other health conditions. The approval of XPOVIO in combination with bortezomib and dexamethasone is a very welcomed addition to the treatment options for Canadian MM patients as it provides patients with a unique, effective oral option that seems to be very well tolerated when used appropriately."
About XPOVIO (selinexor)
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.
XPOVIO is a registered trademark of Karyopharm Therapeutics Inc. and is used by FORUS Therapeutics Inc. under license.