(Reuters) – Exelixis Inc said a late-stage trial of its experimental thyroid cancer drug met the main goal of improving survival of patients without disease progression, compared with a dummy drug.
The drug cabozantinib significantly improved median progression-free survival (PFS) by 7.2 months compared with a placebo. The median PFS for patients taking cabozantinib was 11.2 months versus 4 months for those on placebo.
The trial, named EXAM, is being conducted under a special protocol assessment (SPA) agreement with the U.S. Food and Drug Administration.
SPA provides a company with a written agreement that the design and analysis of the trial are adequate to support a marketing application submission with the FDA.
Exelixis said it was requesting permission to begin a rolling submission of the new drug application for cabozantinib in advanced medullary thyroid cancer and expects the filing will be completed in the first half of 2012.
Shares of the company closed at $5.99 on Friday on Nasdaq.
(Reporting by Esha Dey in Bangalore; Editing by Roshni Menon)