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

FRIMLEY, England - 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 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. 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. 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). 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. www.liferaftgroup.org/gist_recurrence.html, last accessed 14.04.09

8. Cancerbackup, Gastrointestinal stromal tumours(GIST); 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? ; 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

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Notes to Editors

FRIMLEY, England, May 8 /PRNewswire/ –

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:

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

About Novartis

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Source: Novartis Oncology

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. For more information, please contact: Sally Robinson, Novartis Pharmaceuticals UK Ltd, Tel: +44-(0)1276-698086, Fax: +44-(0)1276 698605, Email: sally.robinson at novartis.com. Pip Rogan, Red Health, Tel: +44-(0)207-025-6566, Fax: +44-(0)207-025-6499, Email: pip.rogan at redconsultancy.com