BioCentury
ARTICLE | Company News

FDA panel to discuss cancer candidates

October 23, 2010 12:31 AM UTC

FDA's Oncologic Drugs Advisory Committee will meet on Dec. 2 to discuss a BLA from Bristol-Myers Squibb Co. (NYSE:BMY) for ipilimumab and an NDA from AstraZeneca plc (LSE:AZN; NYSE:AZN) for vandetanib. Ipilimumab, a human mAb against CTLA-4 receptor, is under Priority Review to treat metastatic melanoma in pre-treated patients, with a PDUFA date of Dec. 25. Vandetanib, an EGFR and VEGF receptor kinase inhibitor, is also under Priority Review to treat advanced medullary thyroid cancer (MTC), with a PDUFA date of Jan. 7, 2011. ...