FDA says Genta's Genasense not approvable
US biopharmaceutical firm Genta says it has received notice that its New Drug Application for the use of Genasense (oblimersen sodium) plus chemotherapy in patients with chronic lymphocytic leukemia has been deemed non-approvable by the Food and Drug Administration.
"We are keenly disappointed by this decision," said Raymond Warrell, Genta's chief executive, noting: "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."
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