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FDA Indicates That Genasense(R) Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Data
Date:3/17/2008

Approval Dependent on Outcomes of New Analyses or Confirmatory Trial Conference Call to Discuss Strategy Scheduled for Tuesday March 18, 2008

BERKELEY HEIGHTS, N.J., March 17 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA) announced that the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has decided that available data are not adequate to support approval of Genasense(R) (oblimersen sodium) Injection for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). In a decision issued in response to an appeal filed by Genta in October 2007, CDER acknowledged that complete response, which was the primary endpoint in the pivotal trial, was an appropriate endpoint for assessing efficacy. FDA also agreed that this endpoint was achieved, and that those results supported the efficacy of the drug. However, CDER concluded that at present there was insufficient "confirmatory evidence" in the New Drug Application (NDA) to approve the drug.

CDER recommended two alternatives for exploring the efficacy of Genasense that could provide such confirmatory evidence. One option is to conduct an additional clinical trial. The other option is to collect additional information regarding the clinical course and progression of disease in patients from the previous pivotal trial in order to ascertain whether those data contain sufficient confirmatory evidence. The Company currently plans to pursue both of these options.

"In concluding this process, we are pleased that CDER recognized the merit of our completed study, but more importantly has clarified a path to regulatory approval in this important indication," commented Dr. Loretta M. Itri, Genta's President, Pharmac
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SOURCE Genta Incorporated
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