5 August 2021 - U.S. Food and Drug Administration assigned a Prescription Drug User Fee Act action date of 4 December 2021.
Exelixis today announced that the U.S. FDA has accepted the company’s supplemental New Drug Application for Cabometyx (cabozantinib) as a treatment for patients 12 years and older with differentiated thyroid cancer who have progressed following prior therapy and are radioactive iodine-refractory (if radioactive iodine is appropriate).