FDA News

Genta Appeals FDA Decision on Genasense(R) in CLL

(April 5, 2007)-- Genta announced that the Company has filed a formal appeal of the recent non-approvable decision by the Food and Drug Administration (FDA) for the Company's New Drug Application (NDA) for Genasense(R) (oblimersen sodium) Injection. The NDA proposed the use of Genasense in combination with chemotherapy for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

The appeal was submitted in accordance with the Formal Dispute Resolution process that exists within FDA's Center for Drug Evaluation and Research (CDER). Responses to CDER appeals are typically made within 30 to 60 days. In seeking reconsideration, the appeal reflects several views:

-- Complete response confers clinical benefit in CLL. By definition, a complete response requires elimination of all evident disease, normalization of blood counts, and resolution of symptoms.
-- Complete responses -- the primary endpoint of the Genasense trial --were more than doubled if the chemotherapy regimen included Genasense compared to chemotherapy used alone -- an increase that was
statistically significant.
-- The median duration of complete response exceeded 3 years, at least 50% longer, if the chemotherapy regimen included Genasense - a clinically meaningful and statistically significant increase in a prospectively
specified secondary endpoint.
-- The Genasense study is the only randomized controlled trial ever conducted in this population.
-- The number, type, and severity of adverse reactions encountered with Genasense were comparable to other leukemia drugs, which are managed by specialists.

"On behalf of our patients, we applaud Genta for taking this action, and we urge CDER leadership to reverse the initial Office action", said Dr. Alexandra Levine, Chief Medical Officer at the City of Hope National Medical Center, Duarte, CA, and a hematologist and current member of FDA's Oncology Drug Advisory Committee (ODAC) who did not participate in ODAC's deliberations on Genasense. "It is puzzling that the Office would deny approval to a drug that met both its primary as well as a key secondary endpoint, especially since these findings were observed in the only randomized controlled trial that has ever been conducted in patients with relapsed CLL. These findings were statistically significant, and they represent clear benefit to patients."

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