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HEALTH CANADA APPROVAL OF MYLOTARG® (GEMTUZUMAB OZOGAMICIN)

06/02/20

Only approved antibody-drug conjugate for de novo CD33-positive acute myeloid leukemia (AML)

February 5, 2020 – Pfizer Canada is pleased to announce that Health Canada has granted a Notice of Compliance (NOC) for MYLOTARG (gemtuzumab ozogamicin), in combination with daunorubicin (DNR) and cytarabine (AraC), for the treatment of adult patients with previously untreated, de novo CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukemia.

“AML is a rapidly progressing, life-threatening blood and bone marrow cancer, and the AML community recognizes the need for innovative treatments,” says Dr. Brian Leber, Professor, Division of Hematology and Thromboembolism, Department of Medicine, McMaster University. "Today’s announcement is exciting as it gives patients across Canada living with AML a new treatment option for this devastating disease."

“This approval marks an important milestone for patients, the oncology community and Pfizer, as it makes MYLOTARG the first and only antibody drug conjugate (ADC) available for patients with this type of leukemia in Canada,” said John Leasure, Oncology Canada Lead, at Pfizer.

About Pfizer Canada
Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified health care portfolio includes some of the world’s best known and most prescribed medicines and vaccines. In 2017, Pfizer Inc. invested US$ 7.65 billion globally toward developing safe and effective medicines and took part in more than 180 new R-D collaborations. Canadian headquarters of Pfizer’s Biopharmaceutical Group are located in Kirkland, Quebec. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedInFacebookTwitter or YouTube.

For more information:
Corporate Affairs Canada
Pfizer Canada Media Line: 1-866-9Pfizer (1 866 973-4937)
[email protected]

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