Lundbeck Canada launches a new treatment for a rare form of acute leukemia: acute promyelocytic leukemia

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. 
About Trisenox®
Approved Indication
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: 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. 

SOURCE  Lundbeck Canada Inc 
Media enquiries: 
Celeste Brown Achieve Communications Group (416) 
Dan McCarthy Lundbeck Canada (514) 844-8515 
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CO: Lundbeck Canada Inc
ST: Quebec
-0- Nov/13/2013 13:00 GMT
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