Submission Seeks Approval of Genasense in Relapsed/Refractory Patients
BERKELEY HEIGHTS, N.J., Oct. 25 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA) announced that the Company has completed the filing of the Company's formal appeal to Dr. Janet Woodcock, Acting Director of the Center for Drug Evaluation Research (CDER), at the U.S. Food and Drug Administration (FDA). The appeal asks that CDER approve the use of Genasense(R) (oblimersen sodium) Injection plus chemotherapy for patients with relapsed/refractory chronic lymphocytic leukemia (CLL). In December 2006, FDA issued a non-approvable letter for the Company's New Drug Application (NDA) for Genasense in CLL. This appeal has been submitted in accordance with the Formal Dispute Resolution process that exists within CDER. Responses to CDER appeals are typically made within 30 to 60 days.
The appeal reflects several considerations, including but not limited to the following:
- Complete responses -- the primary endpoint of the trial - were more
than doubled in the Genasense group compared with controls who received
chemotherapy alone. The difference was statistically significant.
- Complete response confers clinical benefit in CLL. By definition, a
complete response requires elimination of all evidence of disease,
normalization of blood counts, and resolution of symptoms.
- The median duration of complete response in patients who received
Genasense has exceeded 3 years, at least 50% longer compared with
controls, which is clinically meaningful and statistically significant.
Survival information from this study will be updated at the annual
meeting of the Ameri
|SOURCE Genta Incorporated|
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