January 8th, 2020

// New Treatment Approved in Canada for Most Common Type of Leukemia

New Treatment Approved in Canada for Most Common Type of Leukemia

CALQUENCE® (acalabrutinib) is now available for adult patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia

MISSISSAUGA, ON, Jan. 8, 2020 /CNW/ - AstraZeneca Canada today announced that Health Canada has approved Calquence® (acalabrutinib), an oral Bruton's tyrosine kinase (BTK) inhibitor, for the treatment of adult patients with chronic lymphocytic leukemia (CLL), as monotherapy or in combination with obinutuzumab in the first-line setting, and as monotherapy for relapsed/refractory (r/r) disease.1

CLL is the most common type of leukemia in adults, accounting for 44 per cent of all cases in Canada.2 More than 2,200 people in Canada are diagnosed with the disease each year and more than 600 will die from it.3,4 Despite advancements in the treatment of CLL, there is still no cure for the disease and even after successful initial treatment, some patients may relapse, leaving them in need of further innovation.

"CLL is most often diagnosed when patients are more than 60 years old, at a time when they are already dealing with other health conditions related to aging and are trying to maintain the best quality of life," says Antonella Rizza, CEO of Lymphoma Canada. "Today's announcement offers Canadians living with CLL an important new option for this incurable but treatable disease."'

The Canadian approval was granted under Project Orbis, a new international health authority collaboration which provides a framework for simultaneous submission and review of oncology products among international partners.5 Under this collaboration, Health Canada, the U.S. FDA, and the Australian Therapeutic Goods Administration (TGA) collectively reviewed the application for Calquence, making it the second treatment approved as part of the program and the first in hematology. 

"In the last several years, we've been moving away from traditional chemotherapies to more targeted therapies for CLL." said Dr. Carolyn Owen, Alberta Health Services, Calgary. "Health Canada's approval of acalabrutinib provides a new effective and well tolerated treatment option for CLL patients and improves their treatment options."

The Health Canada approval of Calquence was based on positive interim data from two Phase III clinical trials, ELEVATE-TN and ASCEND.6,7 The ELEVATE-TN trial evaluated the safety and efficacy of Calquence in combination with obinutuzumab, a CD20 monoclonal antibody, or Calquence alone versus chlorambucil, a chemotherapy, in combination with obinutuzumab in previously untreated patients with CLL. The ASCEND trial evaluated the efficacy of Calquence in previously treated patients with CLL.Together, the trials showed that Calquence in combination with obinutuzumab or as a monotherapy significantly reduced the relative risk of disease progression or death. Across both trials, the safety and tolerability of Calquence were consistent with its established profile.1

About chronic lymphocytic leukemia (CLL)
Chronic lymphocytic leukemia is the most common type of leukemia in adults, which begins in the bone marrow, and progresses slowly.8  In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections.9 As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells and platelets.9This could result in anaemia, infection and bleeding.9 B-cell receptor signalling through BTK is one of the essential growth pathways for CLL. Many people with CLL do not have any symptoms upon diagnosis, and the disease is often found in blood tests for unrelated health problems.10

About Calquence
Calquence (acalabrutinib; previously known as ACP-196) is a selective inhibitor of Bruton's tyrosine kinase (BTK).1 Calquence binds covalently to BTK, thereby inhibiting its activity, and has demonstrated this with minimal interactions with other immune cells in pre-clinical studies.1,6,7 In B cells, BTK signaling results in activation of pathways necessary for B cell proliferation, trafficking, chemotaxis and adhesion.1 The recommended dose of Calquenceis one 100mg capsule taken orally twice daily (approximately 12 hours apart), until disease progression or unacceptable toxicity.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. November 2019.
2Leukemia and Lymphoma Society of Canada. Facts and Statistics. Available at: https://www.llscanada.org/disease-information/facts-and-statistics#Leukemia. Accessed: November 2019. 
3Lymphoma Society. Cll & SLL. Available at: http://www.lymphoma.ca/lymphoma/cll-sll/about-cll-sll. Accessed: November 2019. 
4Canadian Cancer Society. Chronic lymphocytic leukemia statistics. Available at: https://www.cancer.ca/en/cancer-information/cancer-type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed: November 2019.  
5US FDA. Project Orbis. Available at: https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis Accessed December 2019
6ClinicalTrials.gov. Elevate CLL TN: Study of Obinutuzumab + Chlorambucil, Acalabrutinib (ACP-196) + Obinutuzumab, and Acalabrutinib in Subjects With Previously Untreated CLL. NCT02475681. Available online. Accessed July 2019.
7 Ghia P, Pluta A, Wach M, et al. ASCEND Phase 3 study of acalabrutinib vs. investigator's choice of rituxumab plus idelalisib (idR) or bendamustine (BR) in patients with relapsed/refractory (R/R) chronic lymphocytic leukaemia (CLL). Abstract LB2606 at: European Hematology Association 2019 Annual Meeting. Available online. Accessed July 2019.
8Leukemia and Lymphoma Society of Canada. Chronic lymphocytic leukemia. Available at: https://www.llscanada.org/leukemia/chronic-lymphocytic-leukemia. Accessed: November 2019.
9National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ®)–Patient Version. Available at: https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq. Accessed November 2019.
10American Cancer Society. Signs and Symptoms of Chronic Lymphocytic Leukemia. Available at: https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/detection-diagnosis-staging/signs-symptoms.html. Accessed November 2019.

SOURCE AstraZeneca Canada Inc.


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