FDA Appeal Decision Indicates that Genasense® Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Trial
- Category: DNA RNA and Cells
- Published on Monday, 09 March 2009 01:00
- Hits: 1952
Genta Incorporated 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® (oblimersen sodium) Injection for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL)
BERKELEY HEIGHTS, NJ, USA | March 6, 2009 | 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® (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 December 2008, CDER concluded that new information submitted by the Company in its amended New Drug Application (NDA) was insufficient, and the Agency has recommended conducting a confirmatory clinical trial.
"While disappointed with this decision, we appreciate FDA's clarification of the path to U.S. regulatory approval in this important indication," commented Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development, and Chief Medical Officer. "The Company will discuss this decision with clinical and regulatory authorities before determining our next steps. Genta greatly appreciates the professional and collaborative communications with FDA during this process, and we look forward to working with FDA in addressing their recommended options for securing the confirmatory data."
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.
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company's research platform: DNA/RNA-based Medicines and Small Molecules. Genasense® (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genta is currently recruiting patients to the AGENDA Trial, a global Phase 3 trial of Genasense in patients with advanced melanoma. The leading drug in Genta's Small Molecule program is Ganite® (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. The Company has developed G4544, an oral formulation of the active ingredient in Ganite, that has recently entered clinical trials as a potential treatment for diseases associated with accelerated bone loss. The Company is also developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. Ganite and Genasense are available on a "named-patient" basis in countries outside the United States. For more information about Genta, please visit our website at: http://www.genta.com//.
SOURCE: Genta Incorporated