The European Medicines Agency (EMA) has accepted Pfizer?s filing for regulatory review of axitinib for patients with advanced renal cell carcinoma (RCC) after failure of prior systemic treatment. The new drug is under development by Pfizer.

Axitinib,also known as AG013736, is an oral small molecule tyrosine kinase inhibitor. The investigational drug inhibits multiple targets, including the vascular endothelial growth factors VEGFR-1, VEGFR-2, VEGFR-3 which influence tumor growth, vascular angiogenesis and progression of cancer and platelet derived growth factor receptor (PDGFR), and cKIT (CD117). In addition to positive results in the treatment of renal cell carcinoma (RCC)[1], axitinib has been shown to significantly inhibit growth of breast cancer in xenograft models [2]. Studies also show successful in trials with other tumor types [3]. As an investigational agent, axitinib has not been approved by regulatory agencies in any countries or jurisdictions.

Significantly extended progression-free survival
In 2010 a Phase III trial for previously treated metastatic renal cell carcinoma (mRCC) showed significantly extended progression-free survival when compared to sorafenib(Nexavar?, Bayer Healthcare/Onyx Pharmaceuticals.

European Submission
The European submission is based on Phase III data from the AXIS 1032 trial. Pfizer will present full results from this trial, as well as additional data on axitinib, at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO), being held in Chicago from June 3-7, 2011.

?While the prognosis for patients with advanced RCC has improved dramatically over the past five years thanks to the availability of new treatments, there is still a need for new options in this patient population,? said Garry Nicholson, president and general manager, Pfizer Oncology Business Unit. ?This regulatory filing for our innovative investigational therapy axitinib, as well as ongoing studies of our existing medications, underscores Pfizer?s commitment to patients with advanced RCC and our leadership in helping physicians treat this disease.?

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Each year, approximately 210,000 people worldwide are diagnosed with kidney cancer and nearly 102,000 people are expected to die from the disease. Within the last five years, great advances have been made in the treatment of patients with advanced RCC, the most prevalent form of kidney cancer. However, five-year survival rates for patients with advanced RCC remain low, at around 20%.

Research Program
Axitinib is also being investigated in a randomized Phase III clinical trial in patients with treatment-na?ve as well as previously treated advanced RCC, and in a randomized Phase II clinical trial for the treatment of hepatocellular carcinoma (HCC).

For more information:
[1] Rini B, Rixe O, Bukowski R, Michaelson MD, Wilding G, et al. AG-013736, a multi-target tyrosine kinase receptor inhibitor, demonstrates anti-tumor activity in a Phase 2 study of cytokine-refractory, metastatic renal cell cancer (RCC). ASCO Proceedings Abstract 4509
[2] Wilmes LJ, Pallavicini MG, Fleming LM, Gibbs J, Wang D, et al. AG-013736, a novel inhibitor of VEGF receptor tyrosine kinases, inhibits breast cancer growth and decreases vascular permeability as detected by dynamic contrast-enhanced magnetic resonance imaging. Magn Reson Imaging 25(3):319-27
[3] Rugo HS, Herbst RS, Liu G, Park JW, Kies MS, et al. Phase I trial of the oral antiangiogenesis agent AG-013736 in patients with advanced solid tumors: pharmacokinetic and clinical results. J Clin Oncol. 23(24):5474-83

Clinical Trial:
[A] Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer.
[B] Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer

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