FDA to Review Expanded Indication for Cabozantinib

FDA to Review Expanded Indication for Cabozantinib
FDA to Review Expanded Indication for Cabozantinib

Exelixis announced that it has completed the submission of its rolling New Drug Application (NDA) with the Food and Drug Administration (FDA) and requested Priority Review for cabozantinib (tablet formulation) as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy.

The NDA submission is based on results from the Phase 3 trial, METEOR, which compared cabozantinib to everolimus in advanced RCC patients who experienced disease progression after VEGF receptor tyrosine kinase inhibitor therapy. Results from the trial demonstrated that cabozantinib had a 42% reduction in the rate of disease progression or death vs. everolimus, meeting the trial's primary endpoint of improving progression-free survival. Detailed findings were presented at the European Cancer Congress in September 2015 and published in The New England Journal of Medicine.

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Cabozantinib was previously granted Breakthrough Therapy designation by the FDA for this potential indication, as well as, Fast Track designation earlier this year.

Cabozantinib is a tyrosine kinase inhibitor which inhibits the activity of MET, VEGF receptors, AXL and RET. It is currently marketed as Cometriq (capsule formulation) in the United States for the treatment of progressive, metastatic medullary thyroid cancer (MTC).

For more information call (650) 837-7000 or visit Exelixis.com.

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