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FDA approves GlaxoSmithKline's VOTRIENT(TM) for advanced renal cell cancer
Date:10/19/2009

nths of median PFS with VOTRIENT versus 4.2 months with placebo.

The most common adverse events occurring in greater than or equal to 20% of subjects treated with VOTRIENT included diarrhea, hypertension, hair color changes, nausea, anorexia, and vomiting. Grade 3/4 adverse events among these toxicities that differed by greater than or equal to 2% included abnormal liver function, hypertension, diarrhea, asthenia, and abdominal pain. Laboratory abnormalities occurring in >10% of patients and more commonly (greater than or equal to 5%) in the pazopanib arm included increased transaminases, hyperglycemia, leukopenia, hyperbilirubinemia, neutropenia, hypophosphatemia, thrombocytopenia, lymphocytopenia, hyponatremia, hypomagnesemia, and hypoglycemia. Drug-related deaths were observed in 1.4% of 290 patients and included hepatic failure (n=2), stroke (n=1), and perforation (n=1). Hepatic dysfunction is included as a boxed warning in the product label. Other Warnings and Precautions in the label relate to QT prolongation and torsade de pointes, hemorrhagic events, arterial thrombotic events, gastrointestinal perforation and fistula, hypertension, impaired wound healing, hypothyroidism, proteinuria, and pregnancy.

VOTRIENT has a broad clinical program across multiple tumor types, with study details available at www.clinicaltrials.gov. More than 2,000 patients have been treated to date in clinical trials. VOTRIENT is not yet approved in any country other than the U.S.

About GSK Oncology

GSK Oncology is dedicated to producing innovations in cancer that will make profound differences in the lives of patients. Through GSK's revolutionary 'bench to bedside' approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector. Our worldwide research in oncology includes collaborations with more than 160 cancer centers. GSK is closing in on cancer
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SOURCE GlaxoSmithKline
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