Exelixis (EXEL) Announces FDA Accepts for Priority Review sNDA for CABOMETYX for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer

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Go back to Exelixis (EXEL) Announces FDA Accepts for Priority Review sNDA for CABOMETYX for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer

Exelixis Announces U.S. FDA Accepts for Priority Review the Supplemental New Drug Application for CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differen

August 5, 2021 8:00 AM EDT

U.S. Food and Drug Administration assigned a Prescription Drug User Fee Act action date of December 4, 2021

The supplemental New Drug Application is based on the phase 3 COSMIC-311 pivotal trial, which demonstrated significant improvement in progression-free survival with CABOMETYX versus placebo

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (NASDAQ:... More