FDA Approves Pazopanib for Kidney Cancer

October 21, 2009 — The US Food and Drug Administration (FDA) has approved pazopanib tablets (Votrient, GlaxoSmithKline) for the treatment of patients with advanced renal cell carcinoma.

Pazopanib is the sixth drug to be approved for the treatment of kidney cancer since 2005. This year, about 49,000 people have been diagnosed with the disease, and 11,000 have died, FDA officials said in a news release.

"The last five years have seen dramatic improvements in treatment options for patients with kidney cancer. Before 2005, the options available offered only limited effectiveness," noted Richard Pazdur, MD, director, Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. Newly approved drugs include sorafenib, sunitinib, temsirolimus, everolimus, and bevacizumab.

FDA approval of pazopanib was based on data from a randomized, double-blind multicenter phase 3 study (n = 435), showing that its use significantly increased progression-free survival relative to placebo (9.2 months vs 4.2 months; P < .001).

The recommended dose of pazopanib is 800 mg taken once daily at least 1 hour before or 2 hours after a meal. Dose reductions to 400 mg are indicated for patients requiring concomitant treatment with strong cytochrome P 450 isoenzyme 3A4 (CYP 3A4) inhibitors; coadministration of strong CYP 3A4 inducers should be avoided.

Adverse events reported in 20% or more of patients receiving pazopanib include diarrhea, hypertension, hair depigmentation, nausea, anorexia, and vomiting.

Increases in serum transaminase and bilirubin levels were also observed, in some cases leading to severe and fatal hepatotoxicity. Liver chemistries should be measured at baseline and regularly during treatment with pazopanib. Dosing reductions are indicated for patients with moderate hepatic impairment; pazopanib is not recommended for patients with severe liver dysfunction.

Caution is advised when treating patients at increased risk for QT interval prolongation; monitoring electrocardiograms and electrolytes should be considered.

Because of the risk for potentially fatal hemorrhagic events, pazopanib should not be used in patients with a history of hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the past 6 months.

Blood pressure should be well-controlled before initiating treatment with pazopanib, and patients should be monitored for hypertension and treated as needed.

Pazopanib can cause fetal harm and should not be used in pregnancy, the FDA said.

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