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NCCN Updates Kidney Cancer Guidelines to Incorporate FDA Approval of Everolimus
Date:4/20/2009

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 angiogenes
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SOURCE National Comprehensive Cancer Network
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