An Oncologist on the FDA Oncology Drug Advisory Committees take on Genasense + Chemotherapy for the treatment of CLL and Genta's decision to file an appeal...
"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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