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
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
"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 expression.
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 fatal.
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
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 lundbeck.ca.
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
Trisenox® is a registered trademark of Lundbeck Canada Inc.
i Source: Uptodate.com accessed 23 April 2013. http://www.uptodate.com/contents/treatment-of-relapsed-or-refractory-acute-promyelocytic-leukemia-in-adults
ii Paulson C, Serebrin A, Turner D, et al. Epidemiology and outcomes of
APL in a large population based Canadian cohort. Haematologica 2012:
iii Trisenox® product monograph. www.lundbeck.com/ca/en
SOURCE: Lundbeck Canada Inc
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