New Angiogenesis Inhibitor Approved for Renal Cell Carcinoma

Cheryl A. Thompson

BETHESDA, MD 20 October 2009—FDA and GlaxoSmithKline on Monday announced the approval of pazopanib, or Votrient, for the treatment of advanced renal cell carcinoma.

The agency said the drug is the sixth medication approved to treat kidney cancer.

Pazopanib, according to the product's labeling (PDF), is taken once daily by mouth at least one hour before or two hours after a meal.

The labeling recommends a daily dose of 800 mg. Patients with moderate hepatic impairment at the start of therapy should receive a daily dose of 200 mg.

The most commonly reported adverse events in patients with advanced renal cell carcinoma who received pazopanib during a randomized study were diarrhea, hypertension, hair color change, nausea, anorexia, and vomiting. These adverse events, according to the labeling, occurred in 21–52% of the 290 pazopanib-treated patients.

In that study, 53% of the pazopanib-treated patients had elevated serum alanine transaminase levels. The same percentage of patients had elevated serum aspartate transaminase levels. GlaxoSmithKline said two pazopanib-treated patients have died of hepatic failure.

Pazopanib's labeling has a boxed warning regarding severe and fatal hepatotoxicity. FDA said health care professionals should order blood tests of liver function before and during pazopanib treatment. The product comes with a medication guide for patients.

GlaxoSmithKline will market Votrient in tablets containing the equivalent of 200 or 400 mg of pazopanib. The tablets should not be crushed.

The company did not immediately respond to a request for information on when the new product will be available.