News Details
NCCN Updates Kidney Cancer Guidelines to Incorporate FDA Approval of Everolimus
NCCN has added everolimus (Afinitor®, Novartis) to the NCCN Guidelines for Kidney Cancer as a recommended treatment for patients with renal cell carcinoma whose disease has progressed after treatment with kinase inhibitors. This recommendation comes on the heels of the March 30, 2009 FDA approval of everolimus based upon results of a clinical trial which showed that the therapy significantly extended progression-free survival in a specific group of patients.
April 20, 2009
FORT WASHINGTON, PA — The National Comprehensive Cancer Network (NCCN) has updated the NCCN Clinical Practice Guidelines in Oncology™ for Kidney Cancer to reflect the recent FDA approval of everolimus (Afinitor®, Novartis) for advanced renal cell carcinoma in patients whose disease has progressed after treatment with kinase inhibitors such as sunitinib (Sutent®, Pfizer Inc.) and sorafenib (Nexavar®, Bayer HealthCare).
The FDA approval is based on recent results of a clinical trial which showed that the growth or spread of tumors was delayed in patients who were being treated with everolimus and that the treatment improved median progression-free survival to 4.9 months compared to 1.9 months in patients who did not receive the treatment.
Based on this trial data, the NCCN Guidelines Panel for Kidney Cancer has added everolimus as a category 1 option for patients with metastatic renal cell carcinoma following failure of tyrosine kinase therapy.
Everolimus targets a protein known as mTOR, which affects tumor cell division, angiogenesis, and cell metabolism. The mTOR pathway integrates signals from nutrients and growth factors and is considered to be a major regulator of cell growth and angiogenesis. By inhibiting the mTOR pathway, everolimus has the potential to block renal cell cancer growth.
Renal cell carcinoma comprises about two percent of all cancer diagnoses; however the rate has steadily increased by two percent per year for the past 65 years, with the reason for the increase being unknown. Researchers do know that smoking and obesity are among the risk factors for renal cell carcinoma development and that several hereditary types of the disease exist.
NCCN Clinical Practice Guidelines in Oncology™ are developed and updated through an evidence-based process with explicit review of the scientific evidence integrated with expert judgment by multidisciplinary panels of physicians from NCCN Member Institutions. The most recent version of this and all the NCCN Guidelines are available free of charge at NCCN.org.