New Drug for Advanced Kidney Cancer Drug Earns FDA Approval
Some patients with advanced kidney cancer that has worsened after receiving other, more traditional cancer treatments now have a new option for treatment.
The U.S. Food and Drug Administration has approved Afinitor (generic everolimus) for the treatment of renal cell cancer, the most common type of kidney cancer. Renal cell cancer begins in the lining of the small tubules in the kidney that filter waste products from the blood. The devastating form of cancer is resistant to radiation therapy, chemotherapy, and other traditional forms of cancer treatment.
When the cancer is confined to the kidney, between 60 and 70 percent of people survive for five years or longer. However, when the cancer has spread to other parts of the body, the survival rate is much lower. About 13,000 patients died from the disease last year, according to the American Cancer Society.
Afinitor, manufactured by Novartis International AG, may be an option for patients with advanced renal cell cancer who have tried cancer therapies, including sunitinib or sorafenib, the FDA said. Afinitor and other targeted cancer therapies like Afinitor have increased the number of months patients can live without the tumor progressing, according to the FDA.
Newer Cancer-Fighting Drugs
Afinitor and other drugs are called kinase inhibitors, which can prevent cancerous tumor growth by interfering with cell communication. It is meant for those patients with advanced renal cell cancer who have already tried another kinase inhibitor, such as Sutent (sunitinib) or Nexavar (sorafenib).
Sutent and Nexavar are multiple kinase inhibitors which act on numerous cellular targets, but 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, the FDA said.
Clinical Trial Finds Afinitor Effective
A clinical trial of Afinitor was stopped early after a preliminary analysis showed the drug effectively slowed tumor growth in patients taking it compared to those not on the drugs. Disease progression was delayed about five months in half of the patients who received Afinitor. Disease progression was delayed just two months in patients who did not receive the drug, according to the study.
Less than 20 percent of patients in the study reported adverse side effects from Afinitor, including inflammation in the mouth, loss of strength, diarrhea, poor appetite, fluid buildup in the extremities, shortness of breath, coughing, nausea, vomiting, rash, and fever. At least half of all patients also experienced anemia, low white blood counts, high cholesterol and high triglycerides and high blood sugar.
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