Skip to Content


Treatment for Chronic Lymphocytic Leukemia

Genta Receives Non-Approvable Notice for Application of Genasense in Patients With Chronic Lymphocytic Leukemia

BERKELEY HEIGHTS, N.J., December 15, 2006 -- Genta Incorporated today announced that the Company has received notice that its New Drug Application (NDA) for the use of Genasense plus chemotherapy in patients with chronic lymphocytic leukemia (CLL) has been deemed non-approvable by the Food and Drug Administration.

"We are keenly disappointed by this decision," said Dr. Raymond P. Warrell, Jr., Genta's 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."

About Genasense

Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.

Posted: December 2006

Related Articles

Genasense (oblimersen sodium) FDA Approval History