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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