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FDA approves Inlyta for treating advanced kidney cancer

Robin Wulffson MD's picture
kidney cancer, renal cell carcinoma, Inlyta, axtinib, Pfizer, cancer treatment

On January 27, The U.S. Food and Drug Administration (FDA) announced that it had approved Inlyta (axitinib), manufactured by Pfizer, Inc., for the treatment of patients with advanced renal cell carcinoma (kidney cancer) who have not responded to other medical treatments. Inlyta works by blocking certain proteins, known as kinases, which play a role in tumor growth and cancer progression. Inlyta is an oral medication that is taken twice daily.

“This is the seventh drug that has been approved for the treatment of metastatic or advanced kidney cell cancer since 2005,” noted Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. He added, “Collectively, this unprecedented level of drug development within this time period has significantly altered the treatment paradigm of metastatic kidney cancer, and offers patients multiple treatment options.”

Other kidney cancer medications that have received FDA approval include sorafenib (2005), sunitinib (2006), temsirolimus (2007), everolimus (2009), bevacizumab (2009) and pazopanib (2009). The safety and effectiveness of Inlyta were evaluated in a randomized, multi-center clinical trial conducted on 723 patients whose disease had progressed on or after treatment with one prior systemic therapy. The study was designed to measure progression-free survival: the time a patient lived without the cancer progressing. Results showed a median progression-free survival of 6.7 months compared to 4.7 months with a standard treatment (sorafenib).

The most common side effects observed in greater than 20% of patients in the clinical study were diarrhea, hypertension (high blood pressure), fatigue, decreased appetite, nausea, dysphonia (loss of voice), hand-foot syndrome (palmar-plantar erythrodysesthesia), weight loss, vomiting, weakness (asthenia), and constipation.

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The FDA recommends that patients with hypertension should have it well-controlled before taking Inlyta. Some patients who took Inlyta experienced bleeding problems, which in some cases were fatal. The FDA notes that patients with untreated brain tumors or gastrointestinal bleeding should not take Inlyta.

Renal cell carcinoma is a type of kidney cancer that starts in the lining of tubules (microscopic tubes) in the kidney. It is the most common type of kidney cancer in adults and occurs most often in men ages 50 - 70. The exact cause is unknown.

Risk factors include:

  • Dialysis treatment
  • Family history of the disease
  • Genetics
  • Smoking
  • Von Hippel-Lindau disease (a hereditary disease that affects the capillaries of the brain, eyes, and other body parts)


  • Abdominal pain
  • Abnormal urine color (dark, rusty, or brown)
  • Back pain
  • Blood in the urine
  • Emaciated, thin, malnourished appearance
  • Enlargement of the veins around a testicle (varicocele)
  • Flank pain
  • Swelling or enlargement of the abdomen
  • Unintentional weight loss of more than 5% of body weight

Other symptoms that can occur with renal cell carcinoma::

  • Constipation
  • Cold intolerance
  • Excessive hair growth in females
  • Paleness
  • Vision abnormalities

Source: FDA