The FDA has approved Afinitor (everolimus) oral tablets for the treatment of advanced kidney cancer that has progressed after treatment with other cancer therapies.
“Afinitor provides an option for patients with advanced renal cell cancer after failure of treatment with the cancer therapies sunitinib or sorafenib,” said Robert Justice, MD, director of the FDA’s Division of Drug Oncology Products.
A kinase inhibitor, Afinitor interferes with cell communication, preventing tumor growth.
In a phase 3 trial, the time without tumor growth more than doubled among patients who received the drug compared with those who received placebo (4.9 vs. 1.9 months).
In addition, Afinitor treatment was associated with a 67% decrease in the risk of disease progression or death, according to a press release issued by the drug’s developer, Novartis. After 10 months of treatment with Afinitor, about 25% of patients still had no tumor growth, the company said.
“This approval provides a new and useful tool for treating advanced renal cell cancer, representing an important step forward in managing this disease,” said Robert J. Motzer, MD, an attending physician at Memorial Sloan-Kettering Cancer Center in New York City. Dr. Motzer was the principal investigator of the Renal Cell Cancer Treatment with Oral RAD001 Given Daily (RECORD-1) trial, which was the basis for the FDA approval.