FDA to give Cephalon drug priority review in CLL
BOSTON, Dec 3 (Reuters) - Cephalon Inc (CEPH.O) said on Monday that U.S. regulators will review its drug Treanda on a priority basis as a treatment for chronic lymphocytic leukemia, or CLL.
When a drug receives "priority review" status, it means the U.S. Food and Drug Administration will assess it and decide whether to approve it within six months, rather than the traditional 10 or more months.
The agency granted "orphan drug" status for Treanda in CLL in August 2007, which would give it seven years of market exclusivity for this indication, if approved.
The company is also studying the drug as a treatment for non-Hodgkin's lymphoma. (Reporting by Toni Clarke, editing by Gerald E. McCormick)
