FDA Says No to Genasense for CLL

BERKELEY HEIGHTS, New Jersey—Genta Incorporated announced that it has received notice that its New Drug Application for the use of Genasense (oblimersen) plus chemotherapy in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) has been deemed nonapprovable by the US Food and Drug Administration (FDA). [See ONI Dec. 2006 for a report on Genta's supporting phase III trial.]

"We are keenly disappointed by this decision," said Dr. Raymond P. Warrell, Jr., Genta' chief executive officer. "We believe that Genasense has amply demonstrated its efficacy and safety in patients with relapsed and refractory CLL in a carefully designed and executed randomized clinical trial. As we decide on next steps with this application, we will continue working to seek worldwide approval of Genasense for patients who have advanced cancer."

Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis. By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatments.