Important catalysts for the first quarter of 2012 include approval decisions on vismodegib for the treatment of adults with advanced basal cell carcinoma (BCC), and on peginesatide for anaemia associated with chronic kidney disease (CKD). Top-line Phase III data are also expected for tivozanib for the treatment of advanced renal cell carcinoma (RCC).The US Food and Drug Administration (FDA) is expected to make a decision by 8 March 2012 regarding the accelerated approval of vismodegib for adults with advanced BCC for whom surgery is not appropriate. In this patient population there are limited treatment options with no standard of care. Vismodegib (developed by Genentech) is a first-in-class oral Hedgehog signalling pathway inhibitor. The single-arm Phase IIERIVANCE BCC study demonstrated substantial overall response rates and median duration of response in patients with advanced BCC.
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