FDA Takes Cabozantinib Off Advisory Committee Agenda; PDUFA Remains and Market Reacts Positively

On Wednesday, the FDA removed Exelixis’ (NASDAQ:EXEL) lead candidate cabozantinib from the agenda of the Oncology Drugs Advisory Committee (ODAC) meeting in early November, but the drug’s November 29 PDUFA date remains the same. EXEL filed a NDA in May and was granted priority review by the FDA, accelerating the approval process for the metastatic medullary thyroid cancer (MTC) treatment. While the drug will no longer be a part of the ODAC meeting in early November, the company has heard nothing on rescheduling the Advisory Panel’s discussion before its PDUFA date; the FDA usually allows time for preparation in advance of a committee meeting. (more…)