Health Canada Approves ONUREG® (azacitidine tablets), First Maintenance Therapy for Patients in Remission from Acute Myeloid Leukemia

ONUREG^® has shown clinically meaningful increase in overall survival for patients  

MONTREAL, Jan. 12, 2021 /CNW/ - Bristol Myers Squibb Canada (BMS) announced today that Health Canada has approved ONUREG^® (azacitidine tablets) for use as the first and only maintenance therapy for adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment, and who are not eligible for hematopoietic stem cell transplantation (HSCT).¹

AML is a heterogeneous clonal disorder characterized by immature myeloid cell proliferation and bone marrow failure, and is the most common form of acute leukemia in adults, accounting for approximately 80 per cent of adult cases.^2,3,4 An estimated 40-60 per cent of patients aged 60 years and older and 60-80 per cent of patients under 60 years old will obtain complete remission through induction chemotherapy (IC); however, 50 per cent will relapse within a year.^5,6 Once a relapse occurs, long-term survival averages at six months.⁷ In 2015, an estimated 1,235 Canadians were diagnosed with AML and the overall incidence rate in Canada is 3.46/100,000 people.^8,9

"While the majority of patients with AML achieve a complete remission with intensive chemotherapy, many remission patients will experience disease relapse, especially if they were not eligible for a stem cell transplant. Until now, there has been no established standard of care for Canadians who are in remission from AML, but are not eligible for a stem cell transplant," noted Dr. Andre Schuh, Princess Margaret Cancer Centre, Toronto. "The approval of ONUREG^® is significant because it gives transplant ineligible patients with AML in remission a new treatment option that may improve their survival".

ONUREG^® is a nucleoside metabolic inhibitor that is taken orally and works by preventing cancer cells from growing. ONUREG^® becomes incorporated into the building blocks of cells (deoxyribonucleic acid (DNA) and ribonucleic acid (RNA)), which interferes with the production of new DNA and RNA. This is thought to kill cancerous cells in leukemia.¹⁰

"The approval of ONUREG^® is an extension of our ongoing commitment to Canadians living with blood cancer," said Al Reba, General Manager, Bristol Myers Squibb Canada. "We are proud that this therapy will help to fill a significant need for Canadians living in remission from AML and hope that it will have a positive impact on their everyday life."

Health Canada's approval of ONUREG^® is based upon findings from the QUAZAR AML-001 clinical trial. The QUAZAR study, a double-blind, randomized, placebo-controlled, multicenter Phase III study, involved adult patients 55 years or older living with AML. In the study, patients were randomized to Onureg or placebo within four months of achieving first CR/CRi following intensive induction chemotherapy and were not eligible for a stem cell transplant.¹¹ In the study, results showed the median overall survival (OS) was significantly longer with ONUREG^® versus placebo: 24.7 months versus 14.8 months [HR 0.69 (95% CI: 0.55, 0.86); p=0.0009], indicating a 31 per cent reduction in the risk of death in the ONUREG^® arm. Relapse-free survival (RFS), the key secondary endpoint in the study, supports the OS results. The median RFS was 10.2 months for ONUREG^® versus 4.8 months for placebo [HR 0.65 (95% CI: 0.52, 0.81); p=0.0001].¹²

About Bristol Myers Squibb Canada
Bristol Myers Squibb Canada Co. is an indirect wholly-owned subsidiary of Bristol Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb global operations, visit www.bms.com. Bristol Myers Squibb Canada Co. delivers innovative medicines for serious diseases to Canadian patients in the areas of cardiovascular health, oncology, and immunoscience. Bristol Myers Squibb Canada Co. employs close to 400 people across the country. For more information, please visit www.bms.com/ca.

About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

SOURCE Bristol Myers Squibb Canada Co.