my personal edition > renal cancer > news
E-Mail this DGNews to a colleague
DGNews
FDA Approves Pazopanib for Advanced Renal Cell Carcinoma
ROCKVILLE, Md -- October 19, 2009 -- The US Food and Drug Administration (FDA) has approved pazopanib (Votrient) for the treatment of advanced renal cell carcinoma.
"The last 5 years have seen dramatic improvements in treatment options for patients with kidney cancer. Before 2005, the options available offered only limited effectiveness," said Richard Pazdur, MD, Office of Oncology Drug Products, FDA's Center for Drug Evaluation and Research, Rockville, Maryland.
The safety and effectiveness of pazopanib was evaluated in a study of 435 patients. The study examined progression-free survival following enrolment in the study, before the tumour began growing again or before the patient died.
Progression-free survival averaged 9.2 months for patients receiving pazopanib compared with 4.2 months for patients who did not receive the drug.
Adverse reactions included diarrhoea, high blood pressure, hair colour changes, nausea, loss of appetite, vomiting, fatigue, weakness, abdominal pain, and headache.
Pazopanib can also cause severe and fatal liver toxicity. Health care professionals should order blood tests to monitor liver function before and during treatment with the drug. Pazopanib should not be used during pregnancy.
The drug has also been associated with heart rhythm irregularities. Patients receiving pazopanib should be monitored with periodic electrocardiograms, which measure heart rhythm, and blood tests to monitor electrolytes since an electrolyte imbalance can lead to an irregular heart rhythm.
SOURCE: US Food and Drug Administration
All contents Copyright (c) 1995-2009 Doctor's Guide Publishing Limited. All rights reserved.
| 
