October 8th, 2019

// Health Canada approves CALQUENCE® (acalabrutinib) for adult patients with previously-treated mantle cell lymphoma (MCL)

Health Canada approves CALQUENCE® (acalabrutinib) for adult patients with previously-treated mantle cell lymphoma (MCL)

Approval of the highly selective Bruton's tyrosine kinase (BTK)
inhibitor in MCL marks AstraZeneca's entry into the treatment of blood cancers

MISSISSAUGA, ON, Oct. 8, 2019 /CNW/ - AstraZeneca Canada today announced the Health Canada approval of Calquence® (acalabrutinib) as an oral therapy for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. A Notice of Compliance for Calquence was granted based on positive data from the ACE-LY-004 trial which demonstrated an 81% overall response rate for patients with relapsed or refractory MCL.1

MCL is a rare B-cell form of non-Hodgkin's lymphoma most common in men over the age of 50. Usually diagnosed in the late stages, MCL often spreads to other organs including the bone marrow, spleen and liver. Many MCL patients initially respond to treatment, but a high rate of relapse may lead to poor prognosis.2

"The results of the ACE-LY-004 trial are very promising for MCL patients," said Dr. John Kuruvilla, Hematologist and Associate Professor of Medicine, University of Toronto. "Calquence is highly selective in targeting BTK and its minimal interactions with other targets means it can offer the potential for reduced toxicity and improved efficacy."

Calquence is a selective inhibitor of Bruton's tyrosine kinase (BTK). Calquence binds irreversibly to BTK to inhibit its activity, and has demonstrated this with minimal interference to other immune cells or kinases in pre-clinical studies.1,3,4,5 

About Mantle Cell Lymphoma (MCL)
MCL is an aggressive B-cell non-Hodgkin lymphoma (NHL) with poor prognosis.2 MCL accounts for approximately 5% to 10% of new NHL cases in Canada each year, with an annual incidence of 0.5 per 100,000 people in Western countries.2,6 The median age at diagnosis is 68 years, and occurs more often in men than women.6 While MCL patients initially respond to treatment, there is a high frequency of recurrence.6

About Calquence
Calquence (acalabrutinib; previously known as ACP-196) is a selective inhibitor of Bruton's tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity, and has demonstrated this with minimal interactions with other immune cells in pre-clinical studies.1,4,5 In B cells, BTK signaling results in activation of pathways necessary for B cell proliferation, trafficking, chemotaxis and adhesion.The recommended dose of Calquenceis one 100mg capsule taken orally twice daily (approximately 12 hours apart), until disease progression or unacceptable toxicity.1 Calquence may be taken with or without food.1

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of primary and specialty care medicines that transform lives. Our primary focus is on three important areas of healthcare: Cardiovascular and Metabolic disease; Oncology; and Respiratory, Inflammation and Autoimmunity. AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients worldwide. In Canada, we employ more than 675 employees across the country and our headquarters are located in Mississauga, Ontario. For more information, please visit the company's website at www.astrazeneca.ca.

1AstraZeneca Canada Inc., Calquence® (acalabrutinib), Product Monograph. August 2019.
2Lymphoma Canada. Non-Hodgkin Lymphoma. NHL Subtypes. Accessed August 2019. Available at: https://www.lymphoma.ca/lymphoma/non-hodgkin-lymphoma/nhl-subtypes#3
3Covey T, Barf T, Gulrajani M, Krantz F, van Lith B, Bibikova E, et al. Abstract 2596: ACP-196: a novel covalent Bruton's tyrosine kinase (Btk) inhibitor with improved selectivity and in vivo target coverage in chronic lymphocytic leukemia (CLL) patients. Cancer Res. 2015;75(15 Supplement):2596.
4Byrd JC, Harrington B, O'Brien S, Jones JA, Schuh A, Devereux S, et al. Acalabrutinib (ACP-196) in relapsed chronic lymphocytic leukemia. N Engl J Med. 2016;374(4):323–32.
5Harrington BK, Gulrajani M, Covey T, Kaptein A, Van Lith B, Izumi R, et al. ACP-196 is a second generation inhibitor of Bruton tyrosine kinase (BTK) with enhanced target specificity. Blood. 2015;126(23):2908.
6Cheah CY, Seymour JF, Wang M. Mantle Cell Lymphoma. J Clin Oncol. 2016; 34(11):1256-1269. Accessed August 2019. Available at: https://www.ncbi.nlm.nih.gov/pubmed/26755518

SOURCE AstraZeneca Canada Inc.


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