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FDA approves everolimus for pancreatic neuroendocrine tumors
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The FDA has approved everolimus to treat patients with progressive pancreatic neuroendocrine tumors that cannot be removed by surgery or that have metastasized.
“Patients with this cancer have few effective treatment options,” Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Afinitor has demonstrated the ability to slow the growth and spread of neuroendocrine tumors of the pancreas.”
The safety and effectiveness of everolimus (Afinitor, Novartis) was studied in a clinical trial of 410 patients with late-stage or locally advanced disease. Patients were assigned to everolimus or placebo. The primary endpoint was PFS. Median PFS in the everolimus group was 11 months vs. 4.6 months in the placebo group. Patients who received placebo were able to receive Afinitor if their disease worsened. The most commonly reported adverse effects associated with everolimus included stomatitis, rash, diarrhea, fatigue, edema, abdominal pain, nausea, fever and headache.
The drug is currently approved to treat patients with advanced renal cell carcinoma after they fail treatment with sunitinib (Sutent, Pfizer) or sorafenib (Nexavar, Bayer) and patients with subependymal giant cell astrocytoma associated with tuberous sclerosis who cannot be treated by surgery, according to an FDA press release.
Afinitor has another trade name, Zortress, and is approved to treat certain adult patients to prevent organ rejection after a kidney transplant. Zortress has a different safety profile in these patients, according to the release.
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