A significant improvement over the gold standard in treating a white
blood cell cancer
DORVAL, QC, June 27, 2011 /CNW/ - Over a decade ago, Canadian patients
diagnosed with chronic myeloid leukemia (CML), celebrated when PrGleevec* (imatinib mesylate) was approved in Canada. Those stricken with
the white blood cell cancer finally had an effective treatment option
that changed their cancer from a terminal disease to a manageable,
chronic illness. Considered groundbreaking in the world of cancer, the
new treatment even made major headlines around the world.
Today, a more effective and well tolerated therapeutic option has been
added to the treatment arsenal in the war against CML. Tasigna*
(nilotinib capsules) 150 mg has been granted a marketing authorization
with conditions by Health Canada for the treatment of adult patients
with newly diagnosed Philadelphia chromosome-positive CML (Ph+ CML) in
the chronic phase (first phase) of the disease.
"We are pleased by Health Canada's approval of Tasigna* for newly
diagnosed CML patients," says Dr. Jeffrey Lipton, a medical oncologist
with Princess Margaret Hospital in Toronto, Ontario. "This means
Canadian physicians now have a more effective option than the current
gold standard which has significant benefit for patients. Whereas
Gleevec* provided a good response for CML patients, targeting cancer
cells, Tasigna* goes even further by putting patients into a faster and
deeper remission, rendering the disease almost undetectable. Most
importantly, disease progression has been markedly reduced."
What is CML?
CML is one of the four types of leukemia.1 It is caused by an abnormal chromosome, called the Philadelphia (Ph+)
chromosome which produces an abnormal cancer protein called Bcr-Abl,
which is responsible for blocking the normal signal that tells the body
to stop producing white blood cells. As a result, CML patients have a
significantly elevated cancerous white blood cell count.
Without treatment, CML typically progresses over three to five years
from the initial (chronic) phase through a transition period
(accelerated phase) to a rapidly fatal form (blast crisis).2
"While absorbing the news of my CML diagnosis was difficult, I was
grateful to learn that excellent targeted therapies existed to help me
manage my disease," says Brian Milsom, a retired pilot from Surrey,
British Columbia, who was diagnosed with CML over 3 years ago. "I was
lucky to gain access to Tasigna* through a clinical trial immediately
after being diagnosed. Since beginning treatment my cancer is virtually
undetectable and I am able to lead the life I had before my diagnosis."
How it works
Taken twice daily as a 300 mg capsule (2 x 150 mg capsules) at
approximately 12 hour intervals, on an empty stomach, Tasigna* works by
inhibiting the proliferation of cells containing the Ph+ chromosome. It
does this by targeting the production of the Bcr-Abl protein, which is
produced only by cells containing the abnormal Ph+ chromosome. This
protein is recognized as the key cause and driver of the overproduction
of cancer-causing white blood cells in patients with Ph+ CML.
"In the past decade, targeted therapies have helped extend patient lives
and improve their quality of life," says Cheryl-Anne Simoneau,
President and CEO of the CML Society of Canada. "However, nearly 40%
of our CML patients need access to newer targeted therapies in order to
stop disease progression and continue to see an improvement in their
quality of life. While we applaud Health Canada's decision to approve
Tasigna, we are asking provincial governments to ensure that their
citizens can access this treatment option in a timely manner. Patients
who receive the right drug, at the right time at the right dose have a
better chance to win their battle over cancer."
Data demonstrates superior efficacy3
The Health Canada approval was based on the Phase III, randomized,
open-label, multicenter ENESTnd trial, also known as (Evaluating
Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+
CML Patients), which compared the efficacy and safety of Tasigna*
versus Gleevec* in adult patients with newly diagnosed Ph+ CML in
The 12 month study, which included 846 patients from 34 countries,
including Canada, demonstrated superiority to the standard of care
Gleevec* in achieving both molecular response (a measure of deep
reduction in Bcr-Abl, considered to be a critical therapeutic milestone
associated with good long-term outcomes for patients)4, 5, 6 and complete cytogenetic response (undetectable Philadelphia chromosome,
which is the hallmark of this cancer).
Tasigna* eliminated Bcr-Abl faster and more deeply than Gleevec* and
resulted in lower rates of cancer progression after 12 months of
The ENESTnd trial is the largest global comparison of two oral therapies
ever conducted in newly diagnosed Ph+ CML patients in chronic phase.
The most commonly reported adverse drug reactions included rash,
pruritus, headache, nausea, fatigue, and myalgia. Most of these
adverse drug reactions were mild to moderate in severity.
On July 22, 2010, Health Canada approved Tasigna* (nilotinib capsules)
with conditions, for the treatment of chronic phase (CP) Philadelphia
chromosome-positive (Ph+) chronic myeloid leukemia (CML) in adult
patients resistant to or intolerant of at least one prior therapy
including Gleevec* (imatinib mesylate).
On September 9, 2008, Health Canada approved Tasigna* (nilotinib
capsules) with conditions, for the treatment of accelerated-phase (AP)
with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia
(CML) in adult patients resistant to or intolerant of at least one
prior therapy including Gleevec* (imatinib mesylate).
Tasigna* was specifically designed - based on the success of Gleevec* -
to preferentially target Bcr-Abl, the key cause and driver of Ph+ CML.
Tasigna* important safety information
Tasigna* prolongs the QT interval. Sudden cardiac deaths have been
reported in patients receiving Tasigna*. Tasigna* should not be used in patients with a known long QT prolongation or
with a persistent QTc of ＞480 msec. Tasigna* should not be used in
patients with uncorrectable hypokalemia (low potassium levels),
hypomagnesemia (low magnesium levels). Hepatotoxicity/Hepatic failure,
pancreatitis and myelosuppression have been reported. Hypokalemia or
hypomagnesemia must be corrected prior to Tasigna* administration and
should be periodically monitored. Drugs known to prolong the QTc
interval and strong CYP3A4 inhibitors should be avoided. Tasigna* must
not be taken with food since its absorption is increased if taken with
For additional information, please refer to the product monograph.
Gleevec* important safety information
The majority of patients experienced adverse events at some point in
time, however, most events were of mild to moderate grade. In adult
clinical trials, drug discontinuation for drug-related adverse events
was observed in 2.4% of newly diagnosed patients, in 5% of patients in
chronic phase, 8% in accelerated phase and 9% in blast crisis.
Rare/serious adverse reactions include: sepsis, pneumonia, depression,
convulsions, cardiac failure, thrombosis/embolism, ileus, pancreatitis,
hepatic failure, exfoliative dermatitis, angioedema, Stevens-Johnson
syndrome, renal failure, fluid retention, edema (including brain, eye,
pericardium, abdomen and lung), hemorrhage (including brain, eye,
kidney and gastrointestinal tract), diverticulitis, gastrointestinal
perforation, tumor hemorrhage/ necrosis, hip osteonecrosis/avascular
For additional information, please refer to the product monograph.
The foregoing press release contains forward-looking statements that can
be identified by forward-looking terminology, such as "to file", "may",
"should", "potential", "promise", "plans", "will", or similar
expressions, or by express or implied discussions regarding potential
new indications or labelling for Tasigna* or regarding potential future
revenues from Tasigna* or Gleevec*. You should not place undue reliance
on these statements. Such forward-looking statements reflect the
current views of management regarding future events, and involve known
and unknown risks, uncertainties and other factors that may cause
actual results with Tasigna* or Gleevec* to be materially different
from any future results, performance or achievements expressed or
implied by such statements. There can be no guarantee that Tasigna*
will be approved for any additional indications or labeling in any
market. Nor can there be any guarantee that Tasigna* or Gleevec* will
achieve any particular levels of revenue in the future. In particular,
management's expectations regarding Tasigna* and Gleevec* could be
affected by, among other things, unexpected clinical trial results,
including unexpected new clinical data and unexpected additional
analysis of existing clinical data; unexpected regulatory actions or
delays or government regulation generally; the company's ability to
obtain or maintain patent or other proprietary intellectual property
protection; competition in general; government, industry and general
public pricing pressures; the impact that the foregoing factors could
have on the values attributed to the Novartis Group's assets and
liabilities as recorded in the Group's consolidated balance sheet, and
other risks and factors referred to in Novartis AG's current Form 20-F
on file with the US Securities and Exchange Commission. Should one or
more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from
those anticipated, believed, estimated or expected. Novartis is
providing the information in this press release as of this date and
does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new
information, future events or otherwise.
About Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc. provides healthcare solutions that
address the evolving needs of patients and societies. Focused solely on
healthcare, Novartis offers a diversified portfolio to best meet these
needs: innovative medicines, cost-saving generic pharmaceuticals,
preventive vaccines, diagnostic tools and consumer health products.
Novartis is the only company with leading positions in these areas. In
2010, the Company invested close to $100 million in research and
development and conducted clinical trials across the country seeking
new treatments in Ophthalmology, Respiratory diseases, Neurosciences
(including MS), Immunology and Infectious diseases, Cardiovascular,
Oncology (including Hematology) and organ transplantation. In addition
to Novartis Pharmaceuticals Canada Inc., the Novartis Group consists of
Novartis Animal Health Canada Inc., Novartis Consumer Health Canada
Inc., Alcon Canada Inc. and Sandoz Canada Inc. For further information
about Novartis Canada, please consult www.novartis.ca.
*Tasigna and *Gleevec are registered trademarks.
1 CML Society of Canada: Understanding CML - http://www.cmlsociety.org/?q=node/14. Accessed July 15, 2010.
2 Hematologica 2008; 93(s1): 47 Abstract 0118
3 Tasigna* Product Monograph. Novartis Pharmaceuticals, June 23, 2011.
4 Hochhaus A, O'Brien SG, Guilhot F,et al. IRIS Investigators. Six-year
follow-up of patients receiving imatinib for the first-line treatment
of chronic myeloid leukemia. Leukemia. 2009 Jun;23(6):1054-61.
5 Müller MC, Hanfstein B, Erben P, et al. Molecular response to first
line imatinib therapy is predictive for long term event free survival
in patients with chronic phase chronic myelogenous leukemia - an
interim analysis of the randomized German CML Study IV. Blood (ASH Annual Meeting Abstracts) 2008, 112: Abstract 333.
6 Baccarani M, Cortes J, Pane F, et al. Chronic myeloid leukemia: an
update of concepts and management recommendations of European
LeukemiaNet. J Clin Oncol. 2009 Dec 10;27(35):6041-51.
SOURCE Novartis Pharmaceuticals Canada Inc.
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