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FDA approves everolimus for advanced kidney cancer
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Yesterday, the FDA announced approval of everolimus oral tablets for treatment of patients with advanced renal cell carcinoma after treatment failure with other therapies. According to data, everolimus reduced the risk for disease progression or death by 67% compared with placebo.
In 2008, the FDA granted everolimus (Afinitor, Novartis) priority review status based on its potential to fulfill an unmet medical need for patients with advanced renal cell carcinoma, according to a press release. Everolimus, previously known as RAD001, is a kinase inhibitor that blocks mTOR, thereby disrupting the growth, division and metabolism of cancer cells. The drug is intended for patients who have failed therapy with sunitinib (Sutent, Pfizer) or sorafenib (Nexavar, Bayer Pharmaceuticals).
Approval was based on data from the RECORD-1 trial which demonstrated that compared with placebo everolimus more than doubled the time without tumor growth or death (4.9 vs. 1.9 months) and reduced the risk for disease progression or death by 67% (HR=0.33; 95% CI, 0.25-0.43). RECORD-1 was discontinued in February 2008 after the trial met its primary endpoint of PFS. According to a press release, additional data presented at the 33rd European Society for Medical Oncology Congress demonstrated that after 10 months of treatment with everolimus, about 25% of patients had no tumor growth.
Adverse reactions that occurred in at least 20% of patients included: inflammation in the mouth, loss of strength, diarrhea, poor appetite, fluid build-up in the extremities, shortness of breath, coughing, nausea, vomiting, rash and fever, according to an FDA press release. Laboratory tests confirmed that at least half of patients experienced anemia, low white blood counts, high cholesterol, high triglycerides and high blood sugar.