A conditional marketing authorisation is granted to a medicinal product with a positive benefit/risk assessment that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. A conditional marketing authorisation is renewable annually. As part of the conditions of the conditional marketing authorisation for pazopanib, GSK will be required to provide further data comparing pazopanib with sunitinib. This study is ongoing. About lapatinib
Lapatinib is the first oral, small-molecule, dual-targeted therapy for metastatic breast cancer that over-express ErbB2. Over-expression of ErbB2 has been reported in a variety of human tumours and is associated with poor prognosis and reduced overall survival. Lapatinib inhibits the tyrosine kinase enzyme activities of ErbB1 and ErbB2, which blocks a series of biochemical signals associated with tumour growth. Lapatinib, in combination with capecitabine, is authorised in more than 90 countries worldwide for the treatment of patients with advanced or metastatic breast cancer, whose tumours over-express ErbB2. Patients should have progressive disease following prior therapy, which must include an anthracycline, a taxane, and trastuzumab in the metastatic setting. GSK is pursuing a comprehensive breast cancer clinical development programme evaluating lapatinib both alone and in combination with other therapies like chemotherapy and other targeted agents across the spectrum of ErbB2-positive breast cancer, from early to metastatic breast cancer. Trials are also ongoing in a range of other solid tumours thatover-express ErbB1 and/or ErbB2. About metastatic breast cancer
Metastatic breast cancer describes stages of the disease when cancer cells break away from a primary breast tumour and spread to other parts of the body via the bloodstream or lymphatic system. The most common areas of the body for breast cancer cells to spread to are the bone, liver, lung, and brain. The lymph glands in the armpits or lower neck may also be affected. The five-year relative survival rate is lower among women with a more advanced stage of cancer at diagnosis(4) with the median survival for women treated for metastatic breast cancer about 2-4 years.(5) About pazopanib
Pazopanib, a once-daily, oral medication, is an angiogenesis inhibitor, which may help prevent the growth of new blood vessels as well as acting directly on the cause of renal cell cancer. Pazopanib is currently being investigated in a broad clinical development programme across multiple tumour types. About RCC
In adults, 85-90 per cent of kidney cancers are RCC.(6) In the EU, there were an estimated 63,300 new cases of kidney cancer and 26,400 deaths due to kidney cancer in 2006.(7) RCC is the most common type of kidney cancer(8). The incidence is rising throughout the world(9), with 208,000 new cases diagnosed annually and over 100,000 deaths.(10) More than 10% of new cases are diagnosed in Western Europe.(11) Nearly 30% of patients with RCC are found to have metastatic disease at diagnosis.(12) About GlaxoSmithKline in Oncology
GSK Oncology is dedicated to producing innovations in cancer that will make profound differences in the lives of patients. Through GSK's revolutionary 'bench to bedside' approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector. Our worldwide research in oncology includes collaborations with more than 160 cancer centres. GSK is closing in on cancer from all sides with a new generation of patient-focused cancer treatments in prevention, supportive care, chemotherapy and targeted therapies. GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com. Tykerb® is the registered trade mark of the GlaxoSmithKline group of companies in the United States and the countries outside Europe. Tyverb® is a registered trademark of the GlaxoSmithKline group of companies in the European Union. Votrient® is a registered trade mark of the GlaxoSmithKline group of companies in the US and the proposed trade name in Europe, Asia-Pacific, Japan and emerging countries. 1. Johnston S, Pippen J, Jr., Pivot X, et al. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol 2009; 27: 5538-46
2. Schwarzberg L. et al. [Lapatinib Plus Letrozole as First-Line Therapy for HER-2+ Hormone Receptor–Positive Metastatic Breast Cancer. The Oncologist 2010; 15:000-000 www.TheOncologist.com
3. Sternberg CN, et al. Pazopanib in Locally Advanced or Metastatic Renal Cell Carcinoma: Results of a Randomized Phase III Trial. J Clin Oncol 2010;28
4. Breast Cancer Facts & Figures 2007-2008. American Cancer Society. http://www.cancer.org.htm. Accessed April 14, 2008.
5. Chung CT, Carlson RW. Goals and objectives in the management of metastatic breast cancer. Oncologist 2003;8 (6):514-520.
6. Eisen T, Christmas T. Epidemiology/aetiology, Clinical Progress in Renal Cancer, 2007.
7. Ferlay J, et al. Estimates of the cancer incidence and mortality in Europe in 2006. Annals of Oncology 2006; 18: 581-592.
8. European Association of Urology. Guidelines on Renal Cell Carcinoma, 2009
9. Murai M and Oya M. Renal cell carcinoma: aetiology, incidence and epidemiology. Curr. Opin. Urol. 2004; 14, 229-233.
10. Parkin DM, Freddie B, Ferlay, J. et al. Global cancer statistics. CA Cancer J Clin. 2005; 55: (2), 74-108.
11. International Agency for Research on Cancer. GLOBOCAN Report, 2002. Accessed December 2009.
12. Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007; 356: 115-124.