Ipsen’s partner Exelixis announces U.S. FDA approval of CABOMETYX® Tablets for previously untreated advanced renal cell carcinoma

Exelixis, today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) tablets for the expanded indication of patients with advanced renal cell carcinoma (RCC).

 

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RCC is the most common form of kidney cancer in adults.

The FDA’s priority review and approval of CABOMETYX was based on results from the randomized phase 2 CABOSUN trial in patients with previously untreated RCC, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus sunitinib, a current standard of care. Today’s label expansion follows the initial FDA approval of CABOMETYX in April 2016 for the treatment of patients with advanced RCC who have previously received anti-angiogenic therapy.

Business Wire Press release

Last update 20/12/2017