NCCN Updates Kidney Cancer Guidelines to Incorporate FDA Approval of Everolimus

NCCN has added everolimus (Afinitor(R), 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.

FORT WASHINGTON, Pa., April 20 /PRNewswire-USNewswire/ -- The National
Comprehensive Cancer Network (NCCN) has updated the NCCN Clinical Practice
Guidelines in Oncology(TM) for Kidney Cancer to reflect the recent FDA
approval of everolimus (Afinitor(R), Novartis) for advanced renal cell
carcinoma in patients whose disease has progressed after treatment with kinase
inhibitors such as sunitinib (Sutent(R), Pfizer Inc.) and sorafenib
(Nexavar(R), 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(TM) 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
21 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.

The NCCN Member Institutions are: City of Hope Comprehensive Cancer Center,
Los Angeles, CA; Dana-Farber/Brigham and Women's Cancer Center | Massachusetts
General Hospital Cancer Center, Boston, MA; Duke Comprehensive Cancer Center,
Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer
Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson
Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney
Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H.
Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL;
Memorial Sloan-Kettering Cancer Center, New York, NY; H. Lee Moffitt Cancer
Center & Research Institute, Tampa, FL; The Ohio State University
Comprehensive Cancer Center - James Cancer Hospital and Solove Research
Institute, Columbus, OH; Roswell Park Cancer Institute, Buffalo, NY; Siteman
Cancer Center at Barnes-Jewish Hospital and Washington University School of
Medicine, St. Louis, MO; St. Jude Children's Research Hospital/University of
Tennessee Cancer Institute, Memphis, TN; Stanford Comprehensive Cancer Center,
Stanford, CA; University of Alabama at Birmingham Comprehensive Cancer Center,
Birmingham, AL; UCSF Helen Diller Family Comprehensive Cancer Center, San
Francisco, CA; University of Michigan Comprehensive Cancer Center, Ann Arbor,
MI; UNMC Eppley Cancer Center at The Nebraska Medical Center, Omaha, NE; The
University of Texas M. D. Anderson Cancer Center, Houston, TX; and
Vanderbilt-Ingram Cancer Center, Nashville, TN.

For more information on NCCN, please visit NCCN.org.

SOURCE National Comprehensive Cancer Network

Megan Martin of NCCN, +1-215-690-0576, martin@nccn.org