Exelixis Completes Submission of New Drug Application for Cabozantinib for the Treatment of Medullary Thyroid Cancer
Exelixis, Inc. (NASDAQ: EXEL) today announced that it has completed the filing of its rolling New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC).
The NDA was submitted under the FDA's Fast Track designation, which is designed to potentially accelerate the review of an investigational therapy for an unmet medical need. As part of the NDA filing, Exelixis has requested Priority Review designation from the FDA. If granted, the FDA's goal for completing the review would be six months from the date of receipt of the final submission.
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