ARTICLE | Company News

Exelixis extends cabozantinib timeline in MTC

July 7, 2011 12:18 AM UTC

Exelixis Inc. (NASDAQ:EXEL) extended its timeline to report top-line data from the Phase III EXAM trial of cabozantinib ( XL184) in medullary thyroid cancer by about three months. The company, which previously expected data mid-year, said late Wednesday the trial needs more time to reach the pre-specified number of progression-free survival (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 submit an NDA by year end. ...