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Glivec(R) is the First Adjuvant Treatment Approved in the UK to Delay Return of Gastrointestinal Cancer After Surgery

May 8, 2009

FRIMLEY, England, May 8 /PRNewswire/ –

– Glivec(R) (imatinib) Now Approved in the UK for Post-Surgery Treatment
of Patients With KIT (CD117)-Positive Gastrointestinal Stromal Tumours
(GIST), who are at Significant Risk of the Cancer Returning After Surgery(1)

– Use of Glivec(R) After Surgery Significantly Reduces Risk of Cancer
Relapse(2)

– If Untreated After Surgery, 50% of patients Will Experience Their
Cancer Returning Within Two Years(3,4)

Glivec(R) has been approved in the UK for the treatment of patients with
the gastrointestinal cancer, KIT (CD117)-positive gastrointestinal stromal
tumours (GIST), who have had surgery to remove their cancer and are at
significant risk of the cancer returning.(1) Data supporting this new use for
Glivec demonstrates that 98% of patients receiving 400mg Glivec daily for a
year after surgery to remove their GIST did not experience their tumours
returning after 12 months compared to 83% of patients taking placebo.(2)

Approximately 900 people in the UK are diagnosed with GIST(5) each year
and approximately 86% of those diagnosed will undergo surgery to remove the
tumour or tumours.(6) However, if left untreated after surgery, almost 50% of
all patients suffer a relapse within two years and recurrent tumours are
often more aggressive and more difficult to treat than the initial
tumours.(3,4,7) The availability of Glivec for this patient population
addresses a previously unmet need for GIST patients.

Roger Wilson, of patient group Sarcoma UK said: “After GIST surgery,
patients have to live with the knowledge that there is around a 50 percent
chance of their cancer returning. For those patients whose GIST does return,
this can be devastating both physically and emotionally, even though Glivec
can manage recurring GISTs. We hope that the future use of Glivec in the
adjuvant setting will help to reduce the risk of GIST recurrence and provide
reassurance to patients who live with the realities of GIST.”

Glivec is now licensed to be used to treat patients at significant risk
of relapse following the removal of their tumour following approval from the
European Medicines Agency (EMEA). The EMEA (the body responsible for the
scientific evaluation of applications for European authorisation for
medicinal products) says that patients who have a low or very low risk of
recurrence should not receive adjuvant treatment.(1)

What is GIST?

GIST is a type of cancer called a soft tissue sarcoma i.e. a cancer of a
supportive or connective tissue in the body such as fat, muscle, blood
vessels, deep skin tissues, nerves, bones and cartilage.(8) GISTs develop
primarily along the gastrointestinal tract (digestive system) and often
spread within the abdomen.(9)

Although the cause of GIST is unknown,(10) 75-80% of people with GIST
carry KIT mutations.(11) KIT is a protein in the body that plays an important
role in the growth and survival of GIST.(12) In patients with GIST, the KIT
protein can mutate and become over active.(5)

The normal role of KIT is to provide the ‘signal’ to cells in the body to
grow and divide: this signal is not given continuously but can be turned ‘on’
and ‘off’ to limit cell division and growth. However, in people with GIST, a
mutation in the DNA causes KIT to be continuously activated. Left ‘on’ all
the time, KIT signals to cells to constantly grow and divide, driving the
growth of GIST.(5)

Glivec in GIST

Glivec is a type of treatment called a tyrosine kinase inhibitor.(13) It
works in GIST by targeting the KIT protein, binding to it and preventing it
from sending continuous signals to the cancer cells to grow and divide.(14)
Glivec has been available to treat people with unresectable GIST (GIST that
cannot be removed through surgery) since 2002, but currently most people who
have surgery to remove their cancer receive no further preventative treatment.

Glivec is now the only treatment approved to delay the return of this
cancer, filling a previously unmet need for GIST patients.

References

1. EMEA opinion
http://www.emea.europa.eu/pdfs/human/opinion/Glivec_65949508en.pdf. Last
accessed 7 May 2009

2. DeMatteo, R. et al. Adjuvant imatinib mesylate after resection of
localised, primary gastrointestinal stromal tumour: a randomised,
double-blind, placebo-controlled trial. The Lancet. Online publication
19/03/09. DOI: 10:1016/S0140-6736(09)60500-6.
http://download.thelancet.com/pdfs/journals/lancet/PIIS0140673609605006.pdf?i
d=aeaa5a245ca1fddb:3c6bded9:1201d7429fe:-15be1237448848073. Last accessed
14.04.09

3. Van den Abbeele A., Benjamin R., Blanke C, et al. Clinical Management
of GIST. Recurrence patterns and prognostic factors for survival. Highlights
From the 2003 CTOS Annual Meeting and Helsinki GIST Symposium.
http://www.ctos.org/newsletter/GIST_Newsletter0404.pdf, last accessed on
14.04.09

4. 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.

5. NHS Cancer improvement. Guidelines for the management of
gastrointestinal stromal tumours (GISTs).
http://www.cancerimprovement.nhs.uk/%5Cdocuments%5Cupper_gi%5Cpathways%5CGIST
_Mngmnt7.pdf, last accessed 14.04.09

6. Novartis Data on File (GLI-001-01)

7. Life Raft Group. Managing Initial Recurrence.
http://www.liferaftgroup.org/gist_recurrence.html, last accessed 14.04.09

8. Cancerbackup, Gastrointestinal stromal tumours(GIST);
http://www.cancerbackup.org.uk/Cancertype/Softtissuesarcomas/Types/GIST, last
accessed 14.04.09

9. Choi et al, Response evaluation of Gastrointestinal Stromal Tumors.
The Oncologist 2008;13(suppl 2):4-7

10. Cancer Research UK, Cancer help, What is the treatment for GIST -
gastrointestinal stromal tumour? ;
http://www.cancerhelp.org.uk/help/default.asp?page=6161, last accessed
14.04.09

11. Rubin BP, Heinrich MC, Corless CL; Gastrointestinal stromal tumour.
Lancet. 2007 May 19;369(9574):1731-41

12. Corless, CL et al. Biology of Gastrointestinal Stromal Tumors. J Clin
Oncol 22:3813-3825.

13. Summary of Product Characteristics. Glivec. Last updated 01/02/2008

14. Joensuu H, Fletcher C, Dimitrijevic S et al. Management of malignant
gastrointestinal stromal tumours. Lancet Oncol 2002; 3: 655-64

(Due to the length of some of these URLs, it may be necessary to copy and
paste the hyperlinks into your Internet browser’s URL address field. Remove
the space if one exists.)

Notes to Editors

About Glivec(R) (Glivec)

Glivec is approved in more than 90 countries including the US, EU and
Japan for the treatment of all phases of Ph+ CML. Glivec is also approved in
the EU, US and other countries for the treatment of patients with KIT
(CD117)-positive gastrointestinal tumours (GIST), which cannot be surgically
removed and/or have already spread to other parts of the body (metastasised).
In Japan, Glivec is approved for the treatment of patients with KIT
(CD117)-positive GIST. In the EU, Glivec is also approved for the treatment
of adult patients with newly diagnosed Ph+ acute lymphoblastic leukaemia (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 leukaemia
(HES/CEL).

    Not all indications are available in every country.
    For summary of product characteristics, please see:

http://emc.medicines.org.uk/document.aspx?documentId=15014

    About Novartis

Novartis AG 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,
preventive vaccines, diagnostic tools, cost-saving generic pharmaceuticals
and consumer health products. Novartis is the only company with leading
positions in these areas. In 2008, the Group’s continuing operations achieved
net sales of USD 41.5 billion and net income of USD 8.2 billion.
Approximately USD 7.2 billion was invested in R&D activities throughout the
Group. Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 96,700 full-time-equivalent associates and operate in more than
140 countries around the world. For more information, please visit
http://www.novartis.com.

SOURCE Novartis Oncology


Source: newswire



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