FDA Extends Review of Genasense NDA Appeal in Chronic Lymphocytic Leukemia

BERKELEY HEIGHTS, N.J., January 14, 2008 /PRNewswire-FirstCall/ -- Genta Incorporated announced today that the Food and Drug Administration (FDA) has extended its review of Genta's appeal of the non- approvable decision for a New Drug Application (NDA) that proposed the use of Genasense(R) (oblimersen sodium injection) plus chemotherapy in patients with relapsed or refractory chronic lymphocytic leukemia. The Company had previously provided guidance that a final decision would be available in the fourth quarter of 2007. Genta now envisions receiving this notification later in the current quarter.