Lundbeck Canada launches a new treatment for a rare form of acute leukemia:
acute promyelocytic leukemia
Trisenox(®) is now available in Canada
MONTREAL, Nov. 13, 2013 /CNW/ - Health Canada has recently approved Trisenox®
(arsenic trioxide) for relapsed or refractory acute promyelocytic leukemia
(APL). This was made possible by a decision from Health Canada's Therapeutic
Products Directorate to remove a prior regulatory prohibition on arsenic
containing drug therapies for use in humans and by granting priority review.
Trisenox® has been available since 2000 for the treatment of relapse or
refractory APL in over 40 countries.
APL is a cancer of the white blood cells characterized by a rapid accumulation
of abnormal white blood cells in the bone marrow and blood, resulting in
anemia, susceptibility to infections, bleeding, and hemorrhage. APL is a
distinct subtype of acute myeloid leukemia (AML) potentially life threatening,
characterized by abnormal promyelocytes and t(15;17) chromosomal translocation
in the vast majority of cases. APL is a rare disease and affects
approximately 10-15% of AML patients.(i,ii)
In Canada, there are approximately 100 to 150 newly diagnosed APL patients
each year, with only 20 to 30 who relapse or become refractory to treatment
per year.(iii) The median age for diagnosis is 40 years (versus 70 years for
other types of AML) and may include paediatric patients.
"Trisenox® is the only chemo-free targeted therapy that provides an
opportunity to cure acute promyelocytic leukemia (APL) patients," says Dr.
Andre Schuh, Head of Leukemia Service, Princess Margaret Hospital, University
Health Network, Toronto. "The approval of Trisenox is an important milestone
for the treatment of APL patients."
"The approval of new, highly effective treatments brings hope for the
thousands of Canadians living with one of the many types of blood cancers and
disorders," said Lorna Warwick,Senior National Director of Mission Programs,
The Leukemia and Lymphoma Society Canada. "We encourage every provincial
health authority to ensure that all refractory or relapse APL patients can
have access to life saving therapies like Trisenox® when they need them."
NEW Health Canada Change to Food and Drug Act: Allow Use of Arsenic in Humans
On May 31st, 2013, Health Canada amended the Food and Drug Act to allow the
use of arsenic trioxide as a medicinal ingredient in humans. This practice
changing decision came about after arsenic trioxide was reviewed by Health
Canada's Drug Status Scheduling Committee (DSSC) against a set of established
and publicly available factors that include, but are not limited to, toxicity,
pharmacological properties and therapeutic uses.
TRISENOX® (arsenic trioxide) is indicated for induction of remission and
consolidation in patients with acute promyelocytic leukemia (APL), which is
refractory to or has relapsed from retinoid and anthracycline therapy, and
whose APL is characterized by the presence of the t(15;17) translocation or
promyelocytic leukemia-retinoic-acid-receptor alpha (PML-RARα) gene
Important Safety Information
Trisenox® has serious warning and precautions.
APL Differentiation Syndrome: Some patients with APL treated with TRISENOX®
have experienced symptoms similar to a syndrome called the retinoic acid-APL
syndrome or APL differentiation syndrome
Acute Cardiac Toxicities (Rhythm Disturbance): Arsenic trioxide can cause QT
prolongation and complete atrioventricular block. QT prolongation can lead to
torsade de pointes, a polymorphic ventricular tachyarrhythmia, which can be
TRISENOX® should be administered under the supervision of a physician who is
experienced in the management of patients with acute leukemia.
For more information, please refer to the complete product monograph.(iii)
Lundbeck Canada in Oncology
"I am very pleased that we are able to make Trisenox® available to Canadians
living with refractory or relapsed APL," said Patrick Cashman, President and
CEO of Lundbeck Canada. "With a growing hematology-oncology portfolio,
Lundbeck Canada is a patient-centric company that strives to give hope,
strength and humanity to Canadian cancer patients."
Montreal-based Lundbeck Canada is a subsidiary of H. Lundbeck A/S, a leading
international research-based pharmaceutical company. Lundbeck has built its
reputation as a leader in specialty treatments. For decades, we've
concentrated our expertise on helping people everywhere fight CNS disorders
such as Alzheimer, depression, anxiety and schizophrenia. Now, we're directing
that same focus and energy to help cancer patients. In addition to the
approval of Trisenox®, Lundbeck also brought Treanda® (bendamustine
hydrochloride for injection) to market for people living with chronic
lymphocytic leukemia and non-Hodgkin lymphoma. For more information, visit
In February 2011, Lundbeck announced that the company had been granted
exclusive rights to Trisenox® in Canada, as well as the commercial rights to
several Cephalon Inc. products in Canada and Latin America. Cephalon Inc. is a
wholly owned subsidiary of Teva Pharmaceutical Industries Ltd.
Trisenox(®) is a registered trademark of Lundbeck Canada Inc.
(i) Source: Uptodate.com accessed 23 April 2013.
(ii) Paulson C, Serebrin A, Turner D, et al. Epidemiology and outcomes of APL
in a large population based Canadian cohort. Haematologica 2012: 97(s1)
(iii) Trisenox® product monograph. www.lundbeck.com/ca/en
SOURCE Lundbeck Canada Inc
Celeste Brown Achieve Communications Group Celeste.firstname.lastname@example.org (416)
Dan McCarthy Lundbeck Canada DMY@lundbeck.com (514) 844-8515
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