Afinitor

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The U.S. Food and Drug Administration approved Afinitor oral tablets
(everolimus) on March 30, 2009 for the treatment of patients with
advanced kidney cancer whose disease has progressed after treatment
with other cancer therapies. Afinitor belongs to a class of drugs called
kinase inhibitors, which interfere with cell communication, preventing tumor
growth. The drug is intended for those patients with advanced renal cell
cancer who have already tried another kinase inhibitor, Sutent (sunitinib)
or Nexavar (sorafenib).

While Sutent and Nexavar are multiple kinase inhibitors (acting on a
number of cellular targets), Afinitor works by blocking a specific protein
known as the mammalian target of rapamycin or mTOR. The protein
blocking action disrupts the growth, division and metabolism of cancer
cells.

A clinical trial studying the safety and effectiveness of Afinitor was
discontinued after an interim analysis showed that, in patients receiving
the drug, the growth or spread of the tumor was delayed when compared
to patients who did not receive the drug. In addition, disease progression
was delayed approximately five months in half of the patients who received
Afinitor. In contrast, disease progression was delayed two months in
patients who did not receive the drug.

What are the common side effects of Afinitor?
The most frequent unwanted side effects in the trial (occurring in at least
20 percent of patients) included inflammation in the mouth, loss of
strength, diarrhea, poor appetite, fluid buildup in the extremities, shortness
of breath, coughing, nausea, vomiting, rash, and fever. Other side effects
include anemia, low white blood counts, high cholesterol and high
triglycerides and high blood sugar.

Afinitor is manufactured by Novartis International AG of Basel, Switzerland.
Sutent is manufactured by Pfizer Inc. of New York. Nexavar is
manufactured by Bayer HealthCare AG, Leverkusen, Germany.

SOURCE FDA Approves Drug for an Advanced Form of Kidney Cancer
FDA NEWS RELEASE March 30, 2009