The US Food and Drug Administration (FDA) has approved Pfizer's Inlyta (axitinib), a kinase inhibitor, for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.

The approval is based on data from the phase 3 AXIS trial, which demonstrated that Inlyta significantly extended progression free survival (PFS) [HR=0.67, 0.54-0.81, P<0.0001] with a median PFS of 6.7 months (95% CI: 6.3, 8.6) compared with 4.7 months (95% CI: 4.6, 5.6) for those treated with sorafenib, a current standard of care for this patient population, representing a 43 per cent 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 States. Approximately 13,000 individuals die of advanced RCC in the US each year. Approximately 60,000 new cases of this tumour are diagnosed in the US annually, about 20 per cent of which have advanced disease at the time of diagnosis. Between 40 and 65 per cent of patients who progress following first-line therapy go on to receive a second-line treatment.

“Even with the advent of targeted therapies, the need remains for additional options for patients with advanced RCC whose disease has progressed following first-line medications,” said Dr Mace Rothenberg, senior vice president of clinical development and medical affairs, Pfizer Oncology Business Unit. “Inlyta is the first targeted therapy to be approved in the US for patients with advanced RCC after failure of one prior systemic therapy based on data demonstrating superior progression-free survival when compared to another FDA-approved, targeted agent.”

“Pfizer has a strong commitment to advancing therapies for patients with advanced RCC,” said Garry Nicholson, president and general manager, Pfizer Oncology Business Unit. “Inlyta is an important addition to our portfolio of treatment options for these patients, which also includes Sutent (sunitinib) and Torisel (temsirolimus).”

Inlyta, a kinase inhibitor, is an oral therapy that was designed to selectively inhibit vascular endothelial growth factor (VEGF) receptors 1, 2 and 3,which are receptors that can influence tumour growth, vascular angiogenesis and progression of cancer (the spread of tumours).

“Through studying this drug we have learned that a VEGFR-targeted therapy can be effective following prior treatment options, including another VEGFR-targeted agent. This is important in helping physicians understand where these medications fit in the treatment armamentarium,” said Dr. Brian I. Rini, Taussig Cancer Institute at Cleveland Clinic, who served as principal investigator of this Pfizer-sponsored study and is a paid consultant to Pfizer Oncology.

"The FDA approval of this new treatment represents a significant benefit for the many patients who are living with this type of kidney cancer and who are in need of additional treatment options," said William Bro, chief executive officer of the Kidney Cancer Association.

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 (HCC). 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.