GenasenseTreatment for Chronic Lymphocytic Leukemia
Aventis and Genta Announce FDA Acceptance and Priority Review of New Drug Application for Genasense in Advanced MelanomaFirst Drug to Target Cancer Cell Death Pathway Comprises First NDA for Systemic Antisense
STRASBOURG, FRANCE and BERKELEY HEIGHTS, NJ., February 6, 2004 -– Aventis and Genta (Nasdaq: GNTA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Genasense (oblimersen sodium), the first systemic antisense therapy for cancer. The NDA proposes the use of Genasense in combination with dacarbazine for the treatment of patients with advanced melanoma who have not previously received chemotherapy. In addition, the FDA granted Priority Review status to the application, which targets an agency action on or before June 8, 2004.
“The FDA’s decision to grant Genasense a priority review underscores the urgent and significant unmet need for an effective therapy for patients with advanced melanoma. Aventis and Genta are committed to developing and bringing Genasense to market to meet this need,” said Frank Douglas, M.D., Executive Vice President of Drug Innovation and Approval, and a Member of the Board of Management at Aventis.
“This New Drug Application represents the first clinical indication for a drug that promotes chemotherapy-induced apoptosis, the first systemic use of an antisense therapy, as well as the first new drug for patients with advanced melanoma in almost 30 years,” said Loretta M. Itri, M.D., Genta’s President, Pharmaceutical Development, and Chief Medical Officer. “During the review period, we will work closely with the FDA as we seek regulatory approval for this potential new treatment option for patients with advanced melanoma.”
Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current treatments for advanced melanoma.
Advanced or malignant melanoma is the most deadly form of skin cancer. The incidence of this disease is increasing by approximately 4% annually in the US. In 2004, the American Cancer Society estimates more than 55,000 cases of malignant melanoma will have been diagnosed. Melanoma is the number one cause of cancer death in women aged 25 to 29.
Source: Aventis www.aventis.com
Posted: February 2004
- FDA Appeal Decision Indicates that Genasense Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Trial - March 9, 2009
- 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
- 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