Drug Approved for Advanced Kidney Cancer
The Food and Drug Administration (FDA) recently approved axitinib (Inlyta) to treat patients with advanced kidney cancer (renal cell carcinoma) whose disease has not responded to one course of treatment with another drug.Renal cell carcinoma is a type of kidney cancer that starts in the lining of tubules in the kidney. Axitinib is a pill taken twice a day that works by blocking certain proteins called kinases that play a role in tumor growth and cancer progression.
“This is the seventh drug that has been approved for the treatment of metastatic or advanced kidney cell cancer since 2005,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “[These approvals have] significantly altered the treatment paradigm of metastatic kidney cancer, and offer patients multiple treatment options.”
The safety and effectiveness of axitinib were evaluated in a randomized, open-label, multicenter clinical study of 723 patients whose disease had progressed during or after treatment with one prior systemic therapy. Results showed a median progression-free survival of 6.7 months versus 4.7 months with a standard treatment (sorafenib).
The most common side effects observed in the clinical study were diarrhea, high blood pressure, fatigue, decreased appetite, nausea, loss of voice, hand-foot syndrome, weight loss, vomiting, weakness, and constipation. Some patients who took axitinib experienced bleeding, which in some cases was fatal. Patients with untreated high blood pressure, untreated brain metastases, or recent gastrointestinal bleeding should not take axitinib.
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