Pfizer says that axitinib, for the treatment of advanced kidney cancer, has been accepted for review by the US food and Drug Administration.
The drug, which was filed in Europe at the beginning of June, is for previously-treated patients with advanced renal cell carcinoma, the most prevalent form of kidney cancer. The US submission is based on Phase III data which found that axitinib extended progression-free survival (PFS) by 6.7 months compared with Bayer/Onyx's Nexavar (sorafenib), which extended PFS by 4.7 months.
Axitinib is an oral drug which inhibits vascular endothelial growthfactor receptors 1, 2 and 3, which can influence the spread and growthof tumours.
Garry Nicholson, head of the the drug giant's Oncology Business Unit, said the filing represents "a significant step towards accomplishing Pfizer's goal of bringing axitinib to advanced RCC patients who are in need of additional, effective treatment options". The company already has two kidney cancer treatments on the market - Sutent (sunitinib) and Torisel (temsirolimus).
Pfizer noted that some 210,000 people worldwide are diagnosed with kidney cancer every year, and about 102,000 patients die of the disease. While "great advances have been made", five-year survival rates for patients with advanced RCC remain low, at around 20%.