The FDA assigns priority review to drugs that, if approved, would offer major advances in treatment or would provide treatment to patients where no adequate therapy exists. Priority review reduces the targeted NDA review time from 10 months to six months.
The FDA has granted orphan drug status for Treanda for chronic lymphocytic leukemia (CLL) in August 2007, which would entitle Cephalon to a seven-year period of marketing exclusivity in the US, if the product is approved for this indication.
Lesley Russell, executive vice president for worldwide medical and regulatory operations, said: “If approved, Treanda will make a meaningful difference as the first new CLL treatment option approved by the FDA since 2001 and could be available as soon as the second quarter of 2008.”