Register / Log In

FDA approves kinase inhibitor for advanced RCC

The FDA has approved the oral kinase inhibitor axitinib (Inlyta) for the treatment of patients with advanced renal cell carcinoma after failure of one prior systemic therapy.

The approval is based on data from the phase III AXIS trial, which demonstrated that axitinib significantly extended progression-free survival ([PFS] HR=0.67, 0.54-0.81, p

Axitinib is designed to selectively inhibit vascular endothelial growth factor (VEGF) receptors 1, 2, and 3.

"Through studying this drug, we have learned that a VEGFR-targeted therapy can be effective following prior treatment options, including another VEGFR-targeted agent," said Brian I. Rini, MD, of Cleveland Clinic’s Taussig Cancer Institute. "This is important in helping physicians understand where these medications fit in the treatment armamentarium."

The most common (≥20%) adverse events occurring in patients receiving axitinib were diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, hand-foot syndrome, weight decreased, vomiting, asthenia, and constipation. The most common (≥10%) grade 3/4 adverse events were hypertension, diarrhea, and fatigue.

Axitinib is also being investigated in a clinical trial in patients with treatment-naïve as well as previously treated advanced RCC. In addition, under a collaborative development agreement between Pfizer and SFJ Pharma Ltd. II, SFJ will conduct a phase III clinical trial in Asia studying the drug for adjuvant treatment of patients at high risk of recurrent RCC following nephrectomy.

Dr. Rini is a consultant/adviser for Pfizer, Inc. and has received research funding from the company.

Go back to this issue of Urology Times eNews.

The 5-alpha-reductase inhibitor dutasteride (Avodart) appears to delay disease progression and the initiation of active treatment in men with low-risk, localized prostate cancer, results of a 3-year international clinical trial indicate.

Researchers have completed a systematic review of prognostic indices used to calculate a patient's life expectancy, and created a Web site that puts these indices in one central location.

A new American Association of Critical-Care Nurses (AACN) Practice Alert stresses the use of pre- and post-catheterization assessments to gauge proper catheter use and to monitor early signs of urinary tract infection.

Brachytherapy alone, or in combination with external beam radiation therapy (EBRT), significantly reduces mortality rates in patients with high-risk prostate cancer, report the authors of a study from Thomas Jefferson University, Philadelphia.