BioCentury
ARTICLE | Clinical News

Votrient pazopanib regulatory update

February 6, 2012 8:00 AM UTC

FDA's Oncologic Drugs Advisory Committee will meet on March 20 to discuss an sNDA from GlaxoSmithKline for Votrient pazopanib to treat advanced soft tissue sarcoma (STS) patients who have received prior chemotherapy. GSK submitted the sNDA for Votrient in July. A 10-month standard review would place the PDUFA date around May; an exact date is not disclosed. Votrient, a broad spectrum inhibitor of VEGF and other tyrosine kinases, is already approved in the U.S. to treat advanced renal cell carcinoma (RCC). ...