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news.Genta Incorporated has said it will appeal the non-approvable notice from the FDA regarding the use of Genasense injection plus chemotherapy in patients with chronic lymphocytic leukemia.
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The appeal will be filed pursuant to the Formal Dispute Resolution process that exists within FDA’s Center for Drug Evaluation and Research (CDER). Genta filed notice reserving its rights to appeal in December 2006 and expects to complete the filing of this appeal during the current calendar quarter.
The phase III trial of Genasense produced positive results. In the trial Genasense patients with relapsed or refractory CLL were randomly assigned to receive fludarabine plus cyclophosphamide (Flu/Cy) chemotherapy with or without Genasense.
The primary endpoint was achieved as there was a statistically significant increase in the proportion of patients who achieved a complete or nodular partial response (CR/nPR). In addition, the duration of CR/nPR was significantly longer for patients treated with Genasense.