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Press Release

Approval of Votrient®(pazopanib) provides first oral targeted cancer therapy for patients with selective advanced soft tissue sarcomas*

GlaxoSmithKline
Posted on: 08 Aug 12
From today, patients in the UK with certain types of soft tissue sarcomas (STS) could benefit from the first oral therapy for advanced stages of the disease. The European Medicines Agency (EMA) has approved Votrient® (pazopanib) for the treatment of adult patients with selective subtypes of advanced STS who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy. Efficacy and safety have only been established in certain STS histological tumour subtypes*.1

“I am delighted that we will now have another systemic treatment option for patients with soft tissue sarcoma. This is a welcome and much needed addition to the treatments currently available and good news for sarcoma patients,” said Professor Ian Judson, Head of Sarcoma Unit and Professor of Cancer Pharmacology, Royal Marsden Hospital, London.

STS are a rare group of cancers that develop in the supporting or connective tissues of the body such as muscle, nerves, cartilage, blood vessels and fat.2 Approximately 600 patients present with advanced STS in the UK each year and the prognosis for these patients is very poor.3,4 From diagnosis of advanced disease, median survival is around 12 months5 and 5-year survival rates are less than 20%.6

The approval for pazopanib in advanced STS is based on the results of the pivotal, randomised, double-blind, placebo controlled, multi-centre, Phase III study called PALETTE (PAzopanib expLorEd in sofT TissuE sarcoma).7 PALETTE evaluated the efficacy and tolerability of pazopanib in 369 patients with certain subtypes of advanced STS who had previously received chemotherapy.7

Pazopanib significantly increased the time that patients remained progression-free compared with placebo (median progression-free survival [PFS]: 4.6 months vs.1.6 months; p<0.001).1 Fifty percent of patients who received pazopanib showed some degree of tumour shrinkage versus 12% of patients in the placebo arm. Pazopanib also doubled the percentage of patients who experienced stabilisation of their disease compared with placebo (54% vs. 27%).8

Erik van Snippenberg, General Manager, GlaxoSmithKline (GSK) UK commented: “The unmet need in cancer treatment remains significant and with cancer incidence and mortality set to double over the next 20 years, GSK is committed to supporting the research and development of innovative new medicines for rare cancers such as STS.”

In England, pazopanib for advanced STS will not be subject to a NICE Single Technology Appraisal due to the small patient population. Funding will be considered at a local level and could include applications for Cancer Drugs Fund (CDF) monies. Reviews by the reimbursement bodies in Scotland and Wales are planned to take place during the second half of 2012.

Pazopanib has a well-characterised and manageable adverse event (AE) profile in advanced STS. The most common AEs observed with pazopanib treatment (experienced by =30% of patients) were fatigue, diarrhoea, nausea, weight decrease, hypertension, decreased appetite, hair colour changes and vomiting. The majority of events were mild to moderate (grade 1 or 2).1,8 Please refer to the Summary of Product Characteristics for further information on the safety profile and special warnings/precautions associated with pazopanib.1

Detailed information on the use of Votrient and its safety profile are described in the Summary of Product Characteristics, which will be published on the EMA website, together with the European Public Assessment Report (EPAR, http://www.ema.europa.eu) and in the Community Register of Medicinal Products on the European Commission’s website (http://ec.europa.eu/health/documents/community-register/html/index_en.htm).

References
1. GlaxoSmithKline. Votrient (pazopanib) Summary of Product Characteristics, August 2012.
2. Sarcoma UK. What is sarcoma? Available at: http://www.sarcoma.org.uk/what-is-sarcoma (Accessed 21 June 2012).
3. National Institute for Health and Clinical Excellence. Costing statement: trabectedin for the treatment of advanced soft tissue sarcoma. London: NICE; February 2010.
4. Schoffski P. Pazopanib in the treatment of soft tissue sarcoma. Expert Rev Anticancer Ther 2012; 12 (6): 711-723.
5. Grimer R, Judson I, Peake D and Seddon B. Guidelines for the management of soft tissue sarcomas. Sarcoma, Volume 2010, Article ID 506182, 15 pages doi:10.1155/2010/506182.
6. Abraham JA, Baldini EH, Butrynski JE. Management of adult soft-tissue sarcoma of the extremities and trunk. Expert Rev. Anticancer Ther 2010; 10(2): 233-248.
7. Van der Graaf WTA, Blay JY, Chawla S, et al. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 2012; 379: 1879-86.
8. Votrient (pazopanib) tablets. FDA Oncology Drug Advisory Committee Briefing Document, March 2012. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM296303.pdf (Accessed 8 June 2012)
9. Pazopanib versus sunitinib in the treatment of locally advanced and/or metastatic renal cell carcinoma (COMPARZ). Further information available at: http://clinicaltrials.gov/ct2/show/NCT00720941?term=comparz&rank=1
10. Fletcher C, et al. Pathology and Genetics of Tumours of Soft Tissue and Bone. World Health Organization Classification of Tumours. 2002.
11. Wibmer C, Leithner A, Zielonke N, Sperl M, Windhager R. Increasing incidence rates of soft tissue sarcomas? A population-based epidemiologic study and literature review. Ann Oncol 2010; 21: 1106-1111.
12. Toro JR, Travis LB, Wu HJ, et al. Incidence patterns of soft tissue sarcomas, regardless of primary site, in the surveillance, epidemiology and end results program. Int J Cancer 2006; 119: 2922-2930.
13. Mendenhall WM, Indelicato DJ, Scarborough MT, et al. The management of adult soft tissue sarcomas. Am J Clin Oncol 2009; 32: 436-442.
14. Wesolowski R. Budd GT. Use of chemotherapy for patients with bone and soft tissue sarcomas. Cleveland J Med 2010; 77 (suppl. 1): S23-S26.

Votrient® is a registered trade mark of the GlaxoSmithKline group of companies.

For more information:
http://www.gsk.com/

Editor's Details

Vanessa Say
Packer Forbes

Last updated on: 08/08/2012

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