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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.

About the National Comprehensive Cancer Network

The National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 25 of the world's leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of oncology practice so patients can live better lives. For more information, visit NCCN.org.

The NCCN Member Institutions are:

  • Fred & Pamela Buffett Cancer Center at The Nebraska Medical Center
  • City of Hope Comprehensive Cancer Center
  • Dana-Farber/Brigham and Women's Cancer Center
    Massachusetts General Hospital Cancer Center
  • Duke Cancer Institute
  • Fox Chase Cancer Center
  • Huntsman Cancer Institute at the University of Utah
  • Fred Hutchinson Cancer Research Center / Seattle Cancer Care Alliance
  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University
  • Mayo Clinic Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Moffitt Cancer Center
  • The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute
  • Roswell Park Cancer Institute
  • Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
  • St. Jude Children's Research Hospital/The University of Tennessee Health Science Center
  • Stanford Cancer Institute
  • University of Alabama at Birmingham Comprehensive Cancer Center
  • UC San Diego Moores Cancer Center
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • University of Colorado Cancer Center
  • University of Michigan Comprehensive Cancer Center
  • The University of Texas MD Anderson Cancer Center
  • Vanderbilt-Ingram Cancer Center
  • Yale Cancer Center/Smilow Cancer Hospital