16 October 2017 - FDA assigns Prescription Drug User Fee Act action date of 15 February 2018.
Exelixis today announced that the U.S. FDA has determined the company’s supplemental new drug application for Cabometyx (cabozantinib) for patients with previously untreated advanced renal cell carcinoma to be sufficiently complete to permit a substantive review.
The FDA granted priority review of the filing and assigned a Prescription Drug User Fee Act action date of February 15, 2018.