The U.S. Food and Drug Administration (FDA) has accepted a new drug application (NDA) for cabozantinib as a treatment for patients with medullary thyroid cancer.
The FDA also granted priority review designation to the NDA for cabozantinib, which is being developed by Exelixis. Priority review is granted to a pharmaceutical product that, if approved, would meet an unmet medical need for a serious and life-threatening condition, the company noted.
The FDA has set an action date of November 29, 2012, for this NDA.
Last fall, patients who received the drug in a clinical trial had a median survival of more than 11 months before death or disease progression, compared with four months for patients who took the placebo, according to the company. The improvement was greater than Exelixis expected.
