Genasense
oblimersen sodium
Treatment for Chronic Lymphocytic LeukemiaGenta Announces the Company Will Appeal FDA Action on New Drug Application of Genasense in Chronic Lymphocytic Leukemia
BERKELEY HEIGHTS, N.J., February 6, 2007 -- Genta Incorporated today announced that the Company will appeal the non-approvable notice from the Food and Drug Administration's (FDA) Office of Oncology Drug Products of its New Drug Application (NDA) for the use of Genasense (oblimersen sodium) Injection plus chemotherapy in patients with chronic lymphocytic leukemia (CLL). The appeal will be filed pursuant to the Formal Dispute Resolution process that exists within FDA's Center for Drug Evaluation and Research (CDER). The Company filed notice reserving its rights to appeal in December 2006 and expects to complete the filing of this appeal during the current calendar quarter.
Genasense in CLL
In the pivotal Phase 3 trial, patients with relapsed or refractory CLL were randomly assigned to receive fludarabine plus cyclophosphamide (Flu/Cy) chemotherapy with or without Genasense. This trial - the first randomized study ever conducted in this population - achieved its primary endpoint, which was a statistically significant increase in the proportion of patients who achieved a complete or nodular partial response (CR/nPR) (17% vs. 7%; P=0.025). In addition, the duration of CR/nPR was significantly longer for patients treated with Genasense (median = not reached but will exceed 36+ mos. in the Genasense group vs. 22 mos. for patients treated with chemotherapy alone).
Prior to randomization on this trial, patients were prospectively stratified according to criteria that reflected their responsiveness to prior chemotherapy. The CR/nPR response to Flu/Cy alone was both equally poor (6-7%) and numerically inferior in all stratification groups. Clear trends, evident across all strata, suggested that the best response to Genasense occurred in patients who had received less extensive therapy. In addition to achieving the prospectively defined, intent-to-treat primary endpoint, patients in the Genasense group who were protocol-defined as "non-refractory" to fludarabine (comprising more than 40% of the total population) achieved:
- A four-fold increase in CR/nPR (25% [13/51] vs. 6% [3/50]; P = 0.016)
- Increased time-to-progression (median = 12 mos. vs. 10 mos.; P = N.S.)
- Increased overall survival (median not reached but exceeding 39+ mos. vs. 33 mos.; P = 0.05)
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
Related Articles:
FDA Accepts Genta's NDA Amendment as Complete Response for Genasense Treatment of Chronic Lymphocytic Leukemia - July 14, 2008
Genta Submits NDA Amendment to FDA for Genasense as Treatment of Chronic Lymphocytic Leukemia - June 6, 2008
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 Receives Non-Approvable Notice for Application of Genasense in Patients With Chronic Lymphocytic Leukemia - December 15, 2006
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
New Drug Applications Archive
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
