ODAC backs Votrient, PegIntron
FDA's Oncologic Drugs Advisory Committee on Monday supported the approval of two cancer products: Votrient pazopanib from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for renal cell carcinoma (RCC) and PegIntron peginterferon alfa-2b from Schering-Plough Corp. (NYSE:SGP) as an adjuvant treatment for melanoma.
The panel voted 10-0 that Votrient had a favorable risk-benefit profile for patients with RCC. ODAC based its decision on a randomized, international Phase III trial in which Votrient resulted in a median progression-free survival of 9.2 months vs. 4.2 months for placebo (p<0.0000001). While the panelists were concerned by an increased potential for hepatotoxicity in the Votrient arm, they felt the benefits of the broad-spectrum inhibitor of VEGF and other tyrosine kinases outweighed the risks. ...