The Removal of Conditions Supports Amgen Canada’s Mission to Serve Patients and its Continued Commitment to Addressing the Unmet Needs Associated with Life Threatening Diseases

MISSISSAUGA, ON (November 1, 2023) – Amgen Canada announced today that BLINCYTO® (blinatumomab for injection) has received full Notice of Compliance (NOC) from Health Canada for the treatment of patients with Philadelphia chromosome-negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second hematologic complete remission with minimal residual disease (MRD) and pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL.1 This supersedes the previously granted Notice of Compliance with Conditions (NOC/c) on 19 Dec 2019 and 28 April 2017, respectively.

Project Orbis is an initiative of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence. It aims to give patients faster access to promising cancer treatments across the globe. Project Orbis partners work together on the review of submissions for cancer drugs.2

“This is a step forward for patients with a rare and life-threatening disease,” said Dr. Daniel Martinez, executive medical director at Amgen Canada Inc. “With the removal of conditions, vulnerable patients will experience streamlined and continued care.”

The full approval was granted based on data from Study 20120215, a Phase 3 randomized, controlled study investigating blinatumomab as consolidation therapy versus intensive standard late consolidation chemotherapy in pediatric subjects with high-risk first relapsed ALL3, for both indications.

About BLINCTYO®
BLINCYTO® is the first and only treatment for MRD in ALL4. It is indicated for the treatment of patients with Philadelphia chromosome-negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second hematologic complete remission with minimal residual disease (MRD) greater than or equal to 0.1%; adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), and pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL.1

About Philadelphia chromosome-negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL)
Acute lymphoblastic leukemia (ALL) is a cancer that starts in stem cells of the blood which develop abnormally. ALL is the most common type of leukemia diagnosed in young children. It is the least common of the 4 major types of leukemia in adults. In about 25% of adults with ALL, the leukemia cells have the Philadelphia (Ph) chromosome. This is an acquired chromosomal abnormality, which means that it occurs some time after birth.5 Almost 85% of cases of ALL begin from B cells (also called B lymphocytes). B lymphoblastic leukemia can have various recurrent cytogenetic abnormalities including CD19.6

About Amgen Canada
As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ont.’s vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new uses for existing medicines in partnership with many of Canada’s leading healthcare, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca.

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.

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CONTACT:
Natasha Bond
Amgen Canada
Ph: 905-285-3007
natasha.bond@amgen.com

References

  1. PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION - Amgen. (n.d.). https://www.amgen.ca/-/media/Themes/CorporateAffairs/amgen-ca/amgen-ca/documents/products/en/blincyto_pm.pdf
  2. Canada, H. (2022, May 10). Government of Canada. Faster access to promising cancer treatments - Canada.ca. https://www.canada.ca/en/health-canada/services/drugs-health-
  3. Franco Locatelli, M. (2021, July 27). Blinatumomab vs chemotherapy among children with relapsed acute lymphoblastic leukemia-reply. JAMA. https://jamanetwork.com/journals/jama/article-abstract/2782308
  4. Commissioner, O. of the. (n.d.). FDA expands approval of blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-expands-approval-blincyto-treatment-type-leukemia-patients-who-have-certain-risk-factor-relapse
  5. Lee, S. (n.d.-a). Classification of acute lymphoblastic leukemia. Canadian Cancer Society. https://cancer.ca/en/cancer-information/cancer-types/acute-lymphoblastic-leukemia-all/what-is-acute-lymphoblastic-leukemia/classification-of-acute-lymphocytic-leukemia
  6. Lee, S. (n.d.). What is acute lymphoblastic leukemia?. Canadian Cancer Society. https://cancer.ca/en/cancer-information/cancer-types/acute-lymphoblastic-leukemia-all/what-is-acute-lymphoblastic-leukemia