BESPONSA™ Approved by Health Canada for the Treatment of Adults with Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia

First and only CD22-directed antibody-drug conjugate indicated for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia

KIRKLAND, QC, April 6, 2018 /CNW/ - Pfizer Canada announced today that Health Canada has approved BESPONSA™ (inotuzumab ozogamicin for injection) as a monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).¹ BESPONSA is the first and only CD22-directed antibody-drug conjugate approved for this indication.

"The approval of BESPONSA adds a much needed option for relapsed or refractory adult B-cell ALL patients," says John Leasure, Pfizer Oncology Canada Lead, Pfizer Canada Inc. "Pfizer Canada is proud to bring the first CD22-directed antibody-drug conjugate to Canadians, demonstrating our commitment to offering innovative new cancer treatments to patients in need."

ALL is a rare and aggressive cancer of the bone marrow and blood, and approximately four of every 10 cases diagnosed are in adults.^2-5 Acute leukemia cells can multiply rapidly, which crowds out healthy blood cells and usually requires aggressive, timely treatment.⁶

Need For New Therapeutic Options
While chemotherapy is used as an initial treatment for ALL, many adult patients do not respond to it or experience relapse, worsening their prognosis.⁷ The five-year overall survival from first relapse for adult patients with acute leukemia is only approximately 10 per cent.⁷ At this stage, the disease can be difficult to treat, leaving patients in need of new therapeutic options.⁸

"Adults diagnosed with acute lymphoblastic leukemia face a poor prognosis, particularly if their disease has relapsed following prior treatment," says Dr. Andre Schuh, Hematologist, Princess Margaret Cancer Centre. "This Health Canada approval represents an important advancement for such patients, who until now have had limited options."

The Health Canada approval of this indication is based on the results of the INO-VATE trial, a randomized, open-label, international, multicenter Phase 3 study that included 326 patients with B-cell precursor ALL.¹ The co-primary endpoints were complete remission/complete remission with incomplete hematologic recovery and overall survival.¹

About Pfizer Canada Inc.
Pfizer Canada Inc. 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. Historically, Pfizer Inc. has invested more than US $7 billion toward developing safe and effective medicines. At Pfizer, we're working together for a healthier world. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on Twitter (twitter.com/PfizerCA) or Facebook (facebook.com/PfizerCanada).

References:
1.	BESPONSA^TMProduct Monograph. March 15, 2018.
2.	National Cancer Institute. Dictionary of Cancer Terms. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/precursor-b-lymphoblastic-leukemia Accessed March 2, 2018.
3.	Canadian Cancer Society. What is Acute Lymphocytic Leukemia? Available at: http://www.cancer.ca/en/cancer-information/cancer-type/leukemia-acute-lymphocytic-all/acute-lymphocytic-leukemia/?region=on Accessed March 2, 2018.
4.	Pulte, D., et al. Survival of Adults with Acute Lymphoblastic Leukemia in Germany and the United States. PLoS ONE, 9(1), e85554. http://doi.org/10.1371/journal.pone.0085554 Accessed March 14, 2018.
5.	American Cancer Society. Key Statistics for Acute Lymphocytic Leukemia. Available at: https://www.cancer.org/cancer/acute-lymphocytic-leukemia/about/key-statistics.html Accessed March 9, 2018.
6.	Mayo Clinic. Leukemia. Available at: https://www.mayoclinic.org/diseases-conditions/leukemia/symptoms-causes/syc-20374373 Accessed March 14, 2018
7.	National Center for Biotechnology Information. The Myth of the Second Remission of Acute Leukemia in the Adult. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3575753/ Accessed March 2, 2018.
8.	Canadian Cancer Society. Prognosis and Survival for Acute Lymphocytic Leukemia. Available at: http://www.cancer.ca/en/cancer-information/cancer-type/leukemia-acute-lymphocytic-all/prognosis-and-survival/?region=on Accessed March 2, 2018.

SOURCE Pfizer Canada Inc.

Manon Genin, Pfizer Canada Inc., 1-866-9PFIZER (973-4937), [email protected]