FDA Grants Priority Review to Expanded Cabozantinib Indication

Exelixis announced that the Food & Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy.

The NDA submission is based on data from the pivotal Phase 3 METEOR trial which evaluated cabozantinib vs. everolimus in patients with advanced RCC who experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor. Results demonstrated cabozantinib with a 42% reduction in the rate of disease progression or death when compared to everolimus, meeting its primary endpoint of improving progression-free survival. Findings were presented at the European Cancer Congress in September 2015 and published in The New England Journal of Medicine.

Cabozantinib previously received Breakthrough Therapy and Fast Track designations from the FDA for the proposed RCC indication. The FDA assigned a Prescription Drug User Fee Act action date of June 22, 2016 for the NDA.

Cabozantinib, a tyrosine kinase inhibitor, is currently approved for the treatment of progressive, metastatic medullary thyroid cancer (MTC) under the brand name Cometriq in capsule form. The tablet formulation is under investigation for the advanced RCC indication.

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