Exelixis is a biotechnology company committed to developing small molecule therapies for the treatment of cancers. The company’s initial efforts are focused almost exclusively on cabozantinib, a proprietary drug it believes will be very effective in the treatment of patients suffering from thyroid cancer.
The company announced today that it has completed the filing of its rolling New Drug Application (NDA) with the U.S. Food and Drug Administration for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer. The application was submitted under the FDA’s ‘fast track’ designation, which has been set up to accelerate the review of an investigational therapy for an unmet medical need.
As part of the regulatory filing, Exelixis requested a ‘priority review’ designation from the FDA. If the request is granted, the FDA should complete the review of the data pertaining to cabozantinib within six months of the date of receipt of the final submission.
Exelixis filed for a priority review based on the results of a pivotal phase 3 trial in patients with advanced medullary thyroid cancer. In October 2011, the company reported top-line results from the trial, demonstrating that it had met its primary endpoint of improving progression-free survival (by 7.2 months) when compared to a placebo.
For further information about Exelixis and its cabozantinib drug, please visit the company’s website at www.exelixis.com
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