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FDA Approves Pfizer Drug for Advanced Kidney Cancer

Cross-section of kidney (National Library of Medicine)

Cross-section of kidney (National Library of Medicine)

The Food and Drug Administration today approved the drug axitinib to treat patients with renal cell carcinoma, a form of advanced kidney cancer, who have not responded to another drug for this type of cancer. The drug is made by Pfizer Inc. in New York and marketed under the brand name Inlyta.

Renal cell carcinoma is the most common form of kidney cancer, which starts in the lining of very small tubes in the kidney. Inlyta works by blocking proteins called kinases that play a role in tumor growth and cancer progression. The drug is taken in pill form twice a day.

Inlyta was tested in a single randomized, open-label, multi-center clinical study of 723 patients whose disease had progressed on or after treatment with one prior systemic therapy. The study measured progression-free survival, the time a patient lives without the cancer progressing. Results showed a median progression-free survival of 6.7 months compared to 4.7 months with sorafenib, a standard treatment.

FDA reports the most common side effects found in more than one in five patients in the clinical study were diarrhea, high blood pressure (hypertension), fatigue, decreased appetite, nausea, loss of voice (dysphonia), hand-foot syndrome (palmar-plantar erythrodysesthesia), weight loss, vomiting, weakness (asthenia), and constipation.

The agency advises that patients with high blood pressure should have it well-controlled before taking Inlyta. Some patients who took Inlyta experienced bleeding problems, which in some cases were fatal.

Read more: Candidate Drug Starves Cancer Cells of Energy Source

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