FDA approves Novartis drug Glivec® label recommending extending treatment to three years for certain GIST patients after surgery
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FDA approves Novartis drug Glivec® label recommending extending treatment to
three years for certain GIST patients after surgery
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* Phase III results showed 54% reduction in risk of recurrence and 55%
reduction in risk of death after three years' adjuvant Glivec in adults
with KIT+ GIST[1]
* Approval builds on vast experience with Glivec, first approved 10 years ago
for treatment of adults with metastatic and/or unresectable KIT+ GIST[2]
* NCCN guidelines updated to include new adjuvant treatment duration in
patients with KIT+ GIST[2]
Basel, February 1, 2012 - Novartis announced today that following a priority
review, the US Food and Drug Administration (FDA) has approved an update to the
Glivec(®) (imatinib)* label to recommend 36 months of treatment after surgery
for adult patients with KIT (CD117)-positive gastrointestinal stromal tumors
(GIST) who met the risk of recurrence inclusion criteria of the pivotal trial.
This treatment regimen has been shown to improve recurrence-free survival (RFS)
and overall survival (OS) for KIT+ GIST patients compared to 12 months of
treatment[3].
The US approval was based on data from an international, multicenter, open-
label, Phase III clinical trial. Results of the study showed that 36 months of
Glivec treatment significantly prolonged RFS compared to 12 months of Glivec
treatment, which was a 54% reduction in the risk of recurrence (p<0.0001). In
addition, 36 months of Glivec treatment resulted in a 55% reduction in the risk
of death compared to one year of treatment (p=0.0187). The median time of
follow-up was 42 months for RFS and 48 months for OS[3].
"This approval represents another important step in the progress of KIT+ GIST
treatment that began a decade ago when Glivec was first approved to treat
metastatic KIT+ GIST," said Hervé Hoppenot, President, Novartis Oncology. "With
the significant survival benefit resulting from three years of adjuvant
treatment, GIST patients now have a more effective regimen to help manage their
disease."
Gastrointestinal stromal tumors are a rare, life-threatening cancer of the
gastrointestinal tract. The major cause of GIST is an abnormal form of the
protein KIT which causes cells to grow uncontrollably and become cancerous[4].
Patients with GIST are at risk of recurrence following complete resection of
primary GIST[5].
In August 2011, the US National Comprehensive Cancer Network (NCCN) updated its
clinical practice guidelines to recommend consideration of at least three years
of adjuvant therapy with Glivec for patients with high-risk GIST[2].
In addition to extending the Glivec label to three-year treatment duration in
patients with KIT+ GIST after surgery, the FDA has agreed that all accelerated
post-approval commitments for this indication have been met, confirming the
clinical benefit of adjuvant treatment with Glivec.
Study details
The SSG XVIII clinical trial was conducted by the Scandinavian Sarcoma Group
(SSG) and the Sarcoma Group of the Arbeitsgemeinschaft Internistische Onkologie
(AIO). This trial was a multicenter, prospective, randomized study for the
evaluation of adjuvant treatment with Glivec of histologically confirmed KIT+
GIST[6].
The primary endpoint of the study was to compare, within the first five years,
recurrence-free survival in patients with a greater than 50% estimated risk of
GIST disease recurrence, following diagnosis and treatment with adjuvant Glivec
for either 12 or 36 months. The secondary endpoints included overall survival
and treatment safety[1].
Three hundred ninety-seven patients entered the study. Inclusion criteria for
risk of recurrence was defined as tumor diameter >5.0 cm and mitotic count >5/50
high power fields (HPFs); or tumor diameter >10.0 cm, any mitotic count; or
tumor of any size with a mitotic count >10/50 HPFs; or tumors ruptured into the
peritoneal cavity.
Recurrence-free survival was longer in the 36-month group compared to the 12-
month group (HR 0.46, 95% CI 0.32-0.65; p<0.0001). Patients assigned to 36
months of Glivec after surgery had longer overall survival (HR 0.45, 95% CI
0.22-0.89; p=0.0187). Almost all patients experienced side effects while taking
Glivec. Glivec was generally well tolerated. The proportion of patients who
discontinued Glivec during the assigned treatment period for reasons other than
GIST recurrence was 26% over the full three- year treatment period in the 36-
month group and 13% in the 12-month group[1].
Novartis provided the study drug and supported the study financially. Additional
funding was received from the Academy of Finland, Cancer Society of Finland,
Sigrid Juselius Foundation and Helsinki University Research Funds.
About Glivec (imatinib)
Glivec(®) (imatinib) is approved in more than 110 countries for the treatment of
all phases of Ph+ CML, for the treatment of adult patients with KIT (CD117)-
positive gastrointestinal stromal tumors (GIST), which cannot be surgically
removed and/or have metastasized and for the treatment of adult patients
following complete surgical removal of KIT+ GIST.
Glivec Important Safety Information
Glivec can cause fetal harm in pregnant woman. Glivec has been associated with
severe edema (swelling) and serious fluid retention. Cytopenias (anemia,
neutropenia, thrombocytopenia) are common, generally reversible and usually
managed by withholding Glivec or dose reduction. Monitor blood counts regularly.
Severe congestive heart failure and left ventricle dysfunction, severe liver
problems including cases of fatal liver failure and severe liver injury
requiring liver transplants have been reported. Use caution in patients with
cardiac dysfunction and hepatic dysfunction. Monitor carefully.
Bleeding may occur. Severe gastrointestinal (GI) bleeding has been reported in
patients with KIT+ GIST. Skin reactions, hypothyroidism in patients taking
levothyroxine replacement, GI perforation, in some cases fatal and tumor lysis
syndrome, which can be life threatening, have also been reported with Glivec.
Correct dehydration and high uric acid levels prior to treatment. Long-term use
may result in potential liver, kidney, and/or heart toxicities; immune system
suppression may also result from long-term use. In patients with
hypereosinophilic syndrome and heart involvement, cases of heart disease have
been associated with the initiation of Glivec therapy. Growth retardation has
been reported in children taking Glivec. The long-term effects of extended
treatment with Glivec on growth in children are unknown.
The most common side effects include fluid retention, muscle cramps or pain and
bone pain, abdominal pain, loss of appetite, vomiting, diarrhea, decreased
hemoglobin, abnormal bleeding, nausea, fatigue and rash. Glivec should be taken
with food and a large glass of water.
Please see full Prescribing Information.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "recommending," "to recommend," or similar expressions,
or by express or implied discussions 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 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; unexpected
manufacturing issues; 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
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2011, the Group's
continuing operations achieved net sales of USD 58.6 billion, while
approximately USD 9.6 billion (USD 9.2 billion excluding impairment and
amortization charges) was invested in R&D throughout the Group. Novartis Group
companies employ approximately 124,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
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* Known as Gleevec(®) (imatinib mesylate) tablets in the US, Canada and Israel.
References
[1] Joensuu H, et al. Twelve vs. 36 months of adjuvant imatinib (IM) as
treatment of operable GIST with a high risk of recurrence: Final results of
a randomized trial (SSGXVIII/AIO). 47th Annual Meeting of the American
Society of Clinical Oncology. Abstract No. LBA1. June 5, 2011.
[2] National Comprehensive Cancer Network (NCCN): Clinical Practice Guidelines
in Oncology: Soft Tissue. Version 2, 2011.
[3] Glivec (imatinib) prescribing information. Basel, Switzerland: Novartis
International AG.
[4] American Cancer Society. Cancer Reference Information. Detailed Guide for
Gastrointestinal Stromal Tumors.
http://www.cancer.org/acs/groups/cid/documents/webcontent/003103-pdf.pdf.
[5] DeMatteo RP, Lewis JJ, Leung D, Mudan SS, Woodruff JM, Brennan MF. Two
hundred gastrointestinal stromal tumors: recurrence patterns and prognostic
factors for survival. Ann Surg. 2000 Jan;231(1):51-8.
[6] Study Comparing 12 Months Versus 36 Months of Imatinib in the Treatment of
Gastrointestinal Stromal Tumor (GIST). Available at:
http://clinicaltrials.gov/show/NCT00116935. Accessed on January 9, 2012.
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Datum: 01.02.2012 - 07:15 Uhr
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