Genasense
oblimersen sodium
Treatment for Chronic Lymphocytic LeukemiaGenta Receives Non-Approvable Notice for Application of Genasense in Patients With Chronic Lymphocytic Leukemia
BERKELEY HEIGHTS, N.J., December 15, 2006 -- Genta Incorporated today announced that the Company has received notice that its New Drug Application (NDA) for the use of Genasense plus chemotherapy in patients with chronic lymphocytic leukemia (CLL) has been deemed non-approvable by the Food and Drug Administration.
"We are keenly disappointed by this decision," said Dr. Raymond P. Warrell, Jr., Genta's Chief Executive Officer. "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."
About Genasense
Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.
Source: Genta Incorporated
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FDA Indicates That Genasense Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Data - March 17, 2008
FDA Extends Review of Genasense NDA Appeal in Chronic Lymphocytic Leukemia - January 14, 2008
Genta Completes Appeal of FDA Decision for Genasense in CLL - October 25, 2007
Genta Appeals FDA Decision on Genasense in CLL - April 4, 2007
Genta Announces the Company Will Appeal FDA Action on New Drug Application of Genasense in Chronic Lymphocytic Leukemia - February 6, 2007
FDA Extends Review Period for Genasense New Drug Application in Chronic Lymphocytic Leukemia - October 30, 2006
Briefing Documents Posted for FDA Committee Review of Genasense New Drug Application - September 5, 2006
Genta Announces FDA's Oncology Drug Advisory Committee Will Review Genasense as Treatment for Chronic Lymphocytic Leukemia - July 27, 2006
Genasense New Drug Application Accepted for Review by FDA - March 1, 2006
Genta Files New Drug Application for FDA Approval of Genasense Plus Chemotherapy for Patients with Advanced or Refractory Chronic Lymphocytic Leukemia - December 29, 2005
Genta Initiates New Drug Application for Genasense in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia - June 30, 2005
Genta Announces Withdrawal of New Drug Application for Genasense in Melanoma - May 13, 2004
FDA Advisory Committee Reviews Genasense For Use in Advanced Melanoma - May 3, 2004
Genta and Aventis Announce Genasense Expanded Access Program for Patients with Advanced Melanoma - April 20, 2004
Aventis and Genta Announce FDA Acceptance and Priority Review of New Drug Application for Genasense in Advanced Melanoma - February 6, 2004
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