Glivec® approved in EU as first post-surgery therapy to reduce risk
of cancer returning in patients with aggressive gastrointestinal
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* Post-surgery use of Glivec shown to reduce the risk of
gastrointestinal stromal tumors (GIST) returning by 89%
* GIST are a rare, aggressive and potentially deadly type of
Basel, May 7, 2009 - Glivec® (imatinib)* received approval from the
European Commission (EC) to become the first and only treatment
available in Europe to reduce the risk of recurrence in adult
patients who are at significant risk of relapse following surgery to
remove gastrointestinal stromal tumors (GIST).
A rare, life-threatening cancer of the gastrointestinal tract, GIST
are known to be aggressive,, returning in as many as half of
all patients within a median of two years after initial
surgery. However, data from a pivotal Phase III study recently
found that when patients with GIST were treated with post-surgery, or
adjuvant, Glivec, the risk of recurrence was reduced by 89%.
The EC decision applies in all 27 European Union (EU) member states,
plus Norway and Iceland. The approval represents the tenth indication
for Glivec in the EU and follows recent approvals for similar
indications in the US, Switzerland and several other countries.
"The approval of Glivec for post-surgery GIST means that for the
first time, patients in Europe with this life-threatening disease
will have a treatment option that can significantly reduce their risk
of GIST coming back after surgery," said Alessandro Riva, MD,
Executive Vice President, Global Head, Novartis Oncology Development.
The EU approval is based on Phase III data from a double-blind,
randomized, multicenter study of 713 GIST patients throughout the US
and Canada whose tumors had been surgically removed. The study,
conducted by the American College of Surgeons Oncology Group
(ACOSOG), compared the recurrence-free survival of patients taking
either Glivec 400 mg daily or placebo for one year immediately
following surgery. The results showed that 98% of the patients
receiving Glivec remained recurrence-free after one year compared
with approximately 82% of those receiving placebo (P<0.0001).
Therefore, the risk of recurrence was reduced by approximately 89%
with Glivec as compared to placebo.
The investigators reported that Glivec therapy was well tolerated by
most patients, with side effects similar to those observed in
previous clinical trials. These side effects include nausea, diarrhea
and swelling (edema).
About gastrointestinal stromal tumors (GIST)
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,, of which approximately 95%
are Kit-positive. Kit is the protein that, when mutated, has been
identified as one of the major causes of GIST. Glivec inhibits the
activity of Kit, as well as several other proteins.
Glivec is approved in more than 90 countries including the US, EU and
Japan, for the treatment of all phases of 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 and EU, Glivec is now 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 and for the treatment of patients with
myelodysplastic/myeloproliferative diseases (MDS/MPD). In addition,
Glivec is approved for hypereosinophilic syndrome and/or chronic
eosinophilic leukemia (HES/CEL).
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 and MDS/MPD;
on hematological response rates in systemic mastocytosis (SM) and
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 "risk," "potentially," "will,"
"estimated," 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
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.
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[1.] 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/
[2.] 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.
[3.] Artinyan, A., et al. Survival from Metastatic Gastrointestinal
Stromal Tumors in the era of Imatinib. ASCO 2008 Abstract 50.
Accessed March 2009.
[4.] Van den Abbeele A., Benjamin R., Blanke C, et al. Clinical
Management of GIST. Recurrence patterns and prognostic factors for
[5.] Glivec® (imatinib) prescribing information. Basel, Switzerland:
Novartis International AG; March 2009.
[6.] Joensuu H. Current perspectives on the epidemiology of
gastrointestinal stromal tumors. European Journal of Cancer
Supplements. March 2006; Volume 4, Issue 3: 4-9.
[7.] The World Factbook. European Union Population. CIA.gov; June
2005. Available from:
Accessed March 2009.
* Known as Gleevec® (imatinib mesylate) tablets in the US, Canada and
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