The FDA has extended its review period for Genta's Genasense application by 90 days. Normally, that would be a sign of trouble for a drug developer. But Genta is distinctly bullish about the news, given the FDA advisory committee's recommendation against approving the leukemia therapy. The committee questioned the significance of Genta's primary endpoint, an event which sent Genta's stock plunging 63 percent. Genta, meanwhile, has submitted new data that it says shows the drug significantly increased the number of lasting remissions when Genasense plus chemotherapy was compared to chemotherapy alone. The FDA now has until January 29 to render its verdict. The FDA isn't bound by the advisory committee's recommendation, but a win for Genta here would be a rare victory in the face of a negative vote.
"We are pleased that the FDA has agreed to consider this new information during their review of the Genasense NDA," commented Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development, and Chief Medical Officer. "Our pivotal trial met its primary endpoint in the only controlled clinical trial ever conducted in this patient population."