Cabozantinib: Phase III ongoing
Exelixis extended its timeline to report top-line data from the Phase III EXAM trial of cabozantinib in MTC by about 3 months. The company, which previously expected data mid-year, said the trial needs more time to reach the pre-specified number of PFS events required for unblinding. Exelixis would not disclose the required number, but added that the trial is "close" to reaching the number. As a result, Exelixis now plans to begin submission of a rolling NDA in 4Q11 and expects to complete the application in 1Q12. Previously, Exelixis hoped to complete an NDA by year end. Exelixis has an SPA from FDA for the trial. Cabozantinib has Orphan Drug designation in the U.S. to treat follicular, medullary and anaplastic thyroid carcinoma, and metastatic or locally advanced papillary thyroid cancer (see BioCentury, May 16). ...