Votrient Approved for Advanced Kidney Cancer
TUESDAY, Oct. 20 -- Votrient (pazopanib) has been approved to treat advanced renal cell carcinoma, a form of kidney cancer in which cancerous cells invade the lining of small tubes in the kidney called tubules, the U.S. Food and Drug Administration said in a news release.
The oral drug is designed to prevent angiogenesis, the growth of blood vessels that tumors need to survive. Five other drugs have been approved to treat kidney cancer since 2005, the agency said.
This year, some 49,000 people have been diagnosed with renal cell carcinoma and 11,000 have died, the FDA said.
In a 435-person clinical trial, the time before a tumor began re-growing or the patient died averaged 9.2 months for people taking Votrient, compared with 4.2 months among those who didn't take the drug.
Possible adverse reactions to Votrient include diarrhea, high blood pressure, hair color changes, nausea, vomiting, fatigue, abdominal pain and headache. The drug also can be highly toxic to the liver, so people taking Votrient should have their liver function closely monitored, the FDA said. The medication also can cause heart rhythm problems.
Since it can harm a fetus, the drug shouldn't be used by pregnant women, the agency said.
Votrient is produced by the British drug maker GlaxoSmithKline.
The FDA has more about this approval.
Posted: October 2009