The FINANCIAL -- Pfizer announced that the U.S. Food and Drug Administration has approved INLYTA, a kinase inhibitor, for the treatment of patients with advanced renal cell carcinoma after failure of one prior systemic therapy, according to Pfizer.

The approval is based on data from the Phase 3 AXIS trial, which demonstrated that INLYTA significantly extended progression free survival with a median PFS of months compared with months for those treated with sorafenib, a current standard of care for this patient population, representing a 43 percent improvement in median PFS compared to sorafenib.

Cancers of the kidney and renal pelvis are among the 10 most commonly diagnosed cancers in the United States1. Approximately 13,000 individuals die of advanced RCC in the U.S. each year2. Approximately 60,000 new cases of this tumor are diagnosed in the U.S. annually1, about 20 percent of which have advanced disease at the time of diagnosis.Between 40 and 65 percent of patients who progress following first-line therapy go on to receive a second-line treatment.

INLYTA, a kinase inhibitor, is an oral therapy that was designed to selectively inhibit vascular endothelial growth factor receptors and which are receptors that can influence tumor growth, vascular angiogenesis and progression of cancer.

Axitinib is also being investigated in a randomized clinical trial in patients with treatment-naïve as well as previously treated advanced RCC, and in a randomized Phase 2 clinical trial for the treatment of hepatocellular carcinoma.Additionally, under a collaborative development agreement between Pfizer and SFJ Pharma Ltd. II, SFJ will conduct a Phase 3 clinical trial in Asia studying axitinib for adjuvant treatment of patients at high risk of recurrent RCC following nephrectomy.

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