In briefing documents posted online Thursday, the FDA staff reviewers said that GlaxoSmithKline plc's (GSK)(GSK.L) Votrient, a proposed treatment for advanced renal cell cancer, a type of kidney cancer, carries a significant risk of severe liver injury.
The FDA staffers said that though Votrient showed a 5-month improvement in median progression free survival or PFS, there is no statistically significant improvement in overall survival. Three deaths were associated with or likely related to liver injury in the clinical studies of Votrient.
The FDA staff pointed that treatment with Votrient showed an excess incidence of moderate to marked increase in ALT (Alanine transaminase), a liver enzyme. ALT is significantly high in hepatitis and other acute liver damage. The other important adverse reactions associated with Votrient are high blood pressure, hemorrhage, arterial and venous thrombosis, gastrointestinal perforation and proteinuria, a kidney disorder resulting in an abnormally high amount of protein in the urine.
GlaxoSmithKline's Votrient faces a review by the FDA's Oncologic Drugs Advisory Committee on Monday, October 5. The FDA generally follows its advisory committee's recommendation, but is not bound to do so.
Since 2005, the FDA has approved five drugs for the treatment of advanced renal cell cancer -- Nexavar by Onyx Pharmaceuticals (ONXX) and Bayer; Sutent by Pfizer Inc. (PFE); Torisel by Wyeth; Afinitor by Novartis AG (NVS) and Avastin by Genentech/Roche.
GSK, which has traded in the range of $27.15-$44.02 for the past twelve month, closed Thursday's trading session at $38.75, down 1.92%. However, in after-hours, the stock gained 1.96% and was at $39.51.
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