GenasenseTreatment for Chronic Lymphocytic Leukemia
Genasense New Drug Application Accepted for Review by FDA
NDA Proposes Use of Genasense Plus Chemotherapy for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
BERKELEY HEIGHTS, N.J., March 1, 2006 -- Genta Incorporated announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for Genasense (oblimersen sodium) Injection. The NDA proposes the use of Genasense plus fludarabine and cyclophosphamide for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The filing was granted an action date by FDA under the Prescription Drug User Fee Act (PDUFA) of October 28, 2006.
"This filing represents the first NDA for a drug that promotes chemotherapy-induced apoptosis in hematologic oncology," said Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development, and Chief Medical Officer. "We plan to work closely with FDA as we seek approval to commercialize this new treatment option for patients with advanced CLL."
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 is studying Genasense in multiple, late-stage, randomized and non-randomized clinical trials, including chronic lymphocytic leukemia, acute myeloid leukemia, malignant melanoma, non-small cell lung cancer, small cell lung cancer, and prostate cancer.
About Chronic Lymphocytic Leukemia
CLL is the most common form of leukemia in adults. According to the American Cancer Society, approximately 8,000 patients will be diagnosed this year. More than 60,000 people in the U.S. currently have CLL. The disease arises in lymphocytes, a type of white blood cell that normally produces antibodies and serves important immune functions. Patients with CLL typically develop symptoms that may progress over a period of years, ultimately producing a generalized depression of immunity, marked increases in the size of spleen, liver and lymph nodes, and impaired production of other normal blood cells. Eventually, these problems may cause life-threatening complications, such as overwhelming infections and fatal bleeding.
Posted: March 2006
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- Genta to Appeal FDA Decision on New Drug Application for Genasense in Patients with Chronic Lymphocytic Leukemia - December 12, 2008
- Genta Receives Complete Response Letter from FDA to Amended Application of Genasense in Patients with Chronic Lymphocytic Leukemia - December 3, 2008
- 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 Announces the Company Will Appeal FDA Action on New Drug Application of Genasense in Chronic Lymphocytic Leukemia - February 6, 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
- 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