– FDA approval based on CheckMate -9ER trial, in which the combination of CABOMETYX and OPDIVO significantly improved overall survival while doubling progression-free survival and objective response rate versus sunitinib as a first-line treatment for patients with advanced RCC –
– Exelixis prepared to fully support expanded indication immediately –
– Application approved prior to Prescription Drug User Fee Act action date of February 20, 2021, and reviewed under the Real-Time Oncology Review pilot program –
San Francisco, CA (UroToday.com) — Exelixis, Inc. announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) for patients with advanced renal cell carcinoma (RCC) as a first-line treatment in combination with OPDIVO® (nivolumab). RCC is the most common form of kidney cancer, which is among the 10 most frequently diagnosed cancers in the U.S. annually.1