GlivecÂ® substantially reduces risk of cancer returning in patients
with life-threatening gastrointestinal stromal tumors, The Lancet
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* Estimated one-year, recurrence-free survival was 98% for
gastrointestinal stromal tumor (GIST) patients taking Glivec vs.
83% for patients taking placebo
* Historically, one in two patients experienced recurrence of
GIST within a median of two years after surgery
* Glivec is the only treatment in the US and Switzerland indicated
to reduce risk of recurrence of GIST after surgery; regulatory
review is underway in the EU
Basel, March 18, 2009 - Data published today online and in an
upcoming print issue of The Lancet show that GlivecÂ®* (imatinib),
when taken after surgery, substantially reduces the rate of
recurrence of Kit-positive gastrointestinal stromal tumors (GIST)
compared with placebo.
The Phase III study published today was led by the American College
of Surgeons Oncology Group (ACOSOG) and examined post-surgery, or
adjuvant, treatment of more than 700 GIST patients. Researchers found
that 98% of patients receiving 400 mg of Glivec daily remained
tumor-free one year after surgery. The study also found Glivec to be
safe and well-tolerated, with a low rate of serious adverse
GIST is a life-threatening cancer of the gastrointestinal tract.
After initial surgery to remove the tumor, GIST can return in one of
two patients within a median of two years.
"The standard of care after surgical removal of primary GIST has been
clinical and radiologic observation, since standard chemotherapeutic
agents have been ineffective in this disease. This frequently
resulted in tumor recurrence," said Ronald DeMatteo, MD, Memorial
Sloan Kettering Cancer Center, New York, NY. "Now, as The Lancet
reports, by treating patients with Glivec after removal of their
initial tumor, we can proactively impact the course of this disease
by delaying, and in some patients possibly preventing, the return of
Glivec was recently approved in the US, Switzerland and several other
countries for the treatment of GIST in the adjuvant setting, based
on the ACOSOG data. This approval represented the tenth indication
for Glivec in the US.
The double-blind, randomized, multicenter study was conducted
throughout the US and Canada. It included 713 GIST patients whose
tumors had been surgically removed. The study compared the
recurrence-free survival (RFS) of patients taking either Glivec 400
mg daily or placebo immediately following surgery. The results showed
that 98% of those receiving Glivec remained recurrence-free one year
following surgery compared with approximately 83% of those receiving
The investigators reported that Glivec therapy was well tolerated by
most patients, with side effects similar to those observed in
previous clinical trials with Glivec. These include nausea, diarrhea
and swelling (edema).
About gastrointestinal stromal tumors (GIST)
Gastrointestinal stromal tumors (GIST) belong to a group of cancers
known as soft tissue sarcomas. The most common sarcomas, they can
be found most often in the stomach and small bowel. In the EU, the
incidence of GIST is estimated to be more than 5,000 cases per
year[5,6], of which approximately 95% are Kit-positive. Median
time to recurrence is approximately two years. Kit (also known as
CD117) is the protein that, when mutated, has been identified as one
of the major causes of GIST. Glivec inhibits the activity of several
proteins, including Kit.
Glivec is approved in more than 90 countries including the US, EU and
Japan, for the treatment of all phases of Philadelphia
chromosome-positive (Ph+) chronic myeloid leukemia (CML). Glivec is
also approved in the US, EU and other countries for the treatment of
patients with Kit (CD117)-positive gastrointestinal tumors (GIST),
which cannot be surgically removed and/or have already spread to
other parts of the body (metastasized). In the US, Glivec was
recently approved for the post-surgery treatment of adult patients
following complete surgical removal of Kit (CD117)-positive
gastrointestinal stromal tumors. In the EU, Glivec is also approved
for the treatment of adult patients with newly diagnosed Ph+ acute
lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy and
as a single agent for patients with relapsed or refractory Ph+ ALL.
Glivec is also approved for the treatment of adult patients with
unresectable, recurrent and/or metastatic dermatofibrosarcoma
protuberans (DFSP) who are not eligible for surgery. Glivec is also
approved for the treatment of patients with
myelodysplastic/myeloproliferative diseases (MDS/MPD). Glivec is also
approved for hypereosinophilic syndrome and/or chronic eosinophilic
The effectiveness of Glivec is based on overall hematological and
cytogenetic response rates and progression-free survival in CML, on
hematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on
hematological response rates in systemic mastocytosis (SM), HES/CEL,
on objective response rates and progression-free survival in
unresectable and/or metastatic GIST, on recurrence free survival in
adjuvant GIST and on objective response rates in DFSP. Increased
survival in controlled trials has been demonstrated only in newly
diagnosed chronic phase CML and GIST.
Not all indications are available in every country.
Important safety information
The majority of patients treated with Glivec in clinical trials
experienced adverse events at some time. Most events were of mild to
moderate grade and treatment discontinuation was not necessary in the
majority of cases.
The safety profile of Glivec was similar in all indications. The most
common side effects included nausea, superficial edema, muscle
cramps, skin rash, vomiting, diarrhea, abdominal pain, myalgia,
arthralgia, hemorrhage, fatigue, headache, joint pain, cough,
dizziness, dyspepsia and dyspnea, dermatitis, eczema and fluid
retention, as well as neutropenia, thrombocytopenia and anemia.
Glivec was generally well-tolerated in all of the studies that were
performed, either as monotherapy or in combination with chemotherapy,
with the exception of a transient liver toxicity in the form of
transaminase elevation and hyperbilirubinemia observed when Glivec
was combined with high dose chemotherapy.
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 and hip osteonecrosis/avascular necrosis.
Patients with cardiac disease or risk factors for cardiac failure
should be monitored carefully and any patient with signs or symptoms
consistent with cardiac failure should be evaluated and treated.
Cardiac screening should be considered in patients with HES/CEL and
patients with MDS/MPD with high level of eosinophils (echocardiogram,
serum troponin level).
Glivec is contraindicated in patients with known hypersensitivity to
imatinib or any of its excipients. Women of childbearing potential
should be advised to avoid becoming pregnant while taking Glivec.
The foregoing release contains forward-looking statements that can be
identified by terminology such as "estimated," "probably" or similar
expressions, or by express or implied discussions regarding potential
new indications or labeling for Glivec, regarding the long-term
impact of a patient's use of Glivec, or regarding potential future
revenues from Glivec. 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 Glivec to be materially different from any future
results, performance or achievements expressed or implied by such
statements. There can be no guarantee that Glivec will be approved
for any additional indications or labeling in any market. Neither can
there be any guarantee regarding the long-term impact of a patient's
use of Glivec. Nor can there be any guarantee that Glivec will
achieve any particular levels of revenue in the future. In
particular, management's expectations regarding Glivec could be
affected by, among other things, unexpected regulatory actions or
delays or government regulation generally; unexpected clinical trial
results, including unexpected new clinical data and unexpected
additional analysis of existing clinical data; 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.
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please visit http://www.novartis.com.
 DeMatteo, R., et al. Adjuvant imatinib mesylate after resection
of localised, primary gastrointestinal stromal tumour: a randomised,
double-blind, placebo-controlled trial. The Lancet. Published online
March 19, 2009. Accessed March 2009. http://www.thelancet.com/
 Van den Abbeele A., Benjamin R., Blanke C, et al. Clinical
Management of GIST. Recurrence patterns and prognostic factors for
 Demetri GD, Benjamin RS, Blanke CD, et al. NCCN task force
report: management of patients with gastrointestinal stromal tumor
(GIST) - update of NCCN clinical practice guidelines. J Natl Compr
Cancer Network, 2007; 2(suppl 1):S1-S26.
 GleevecÂ® (imatinib mesylate) tablets prescribing information.
East Hanover, NJ: Novartis Pharmaceuticals Corporation.
 Joensuu H. Current perspectives on the epidemiology of
gastrointestinal stromal tumors. European Journal of Cancer
Supplements. March 2006; Volume 4, Issue 3: 4-9.
 The World Factbook. European Union Population. CIA.gov; June
2005. Available from:
Accessed March 2009.
* Known as GleevecÂ® (imatinib mesylate) in the US, Canada and Israel.
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