Genasense FDA Approval Status

FDA Approved: No
Brand name: Genasense
Generic name: oblimersen sodium
Company: Genta Incorporated
Treatment for: Chronic Lymphocytic Leukemia

Genasense (oblimersen sodium) is a Bcl-2 antisense oligonucleotide intended for use in the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL).

In December 2008, Genta Incorporated announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for Genasense had not been approved.

Development timeline for Genasense

Date	Article
Mar 9, 2009	FDA Appeal Decision Indicates that Genasense Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Trial
Dec 12, 2008	Genta to Appeal FDA Decision on New Drug Application for Genasense in Patients with Chronic Lymphocytic Leukemia
Dec 3, 2008	Genta Receives Complete Response Letter from FDA to Amended Application of Genasense in Patients with Chronic Lymphocytic Leukemia
Jul 14, 2008	FDA Accepts Genta's NDA Amendment as Complete Response for Genasense Treatment of Chronic Lymphocytic Leukemia
Jun 6, 2008	Genta Submits NDA Amendment to FDA for Genasense as Treatment of Chronic Lymphocytic Leukemia
Mar 17, 2008	FDA Indicates That Genasense Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Data
Jan 14, 2008	FDA Extends Review of Genasense NDA Appeal in Chronic Lymphocytic Leukemia
Oct 25, 2007	Genta Completes Appeal of FDA Decision for Genasense in CLL
Apr 4, 2007	Genta Appeals FDA Decision on Genasense in CLL
Feb 6, 2007	Genta Announces the Company Will Appeal FDA Action on New Drug Application of Genasense in Chronic Lymphocytic Leukemia
Dec 15, 2006	Genta Receives Non-Approvable Notice for Application of Genasense in Patients With Chronic Lymphocytic Leukemia
Oct 30, 2006	FDA Extends Review Period for Genasense New Drug Application in Chronic Lymphocytic Leukemia
Sep 5, 2006	Briefing Documents Posted for FDA Committee Review of Genasense New Drug Application
Jul 27, 2006	Genta Announces FDA's Oncology Drug Advisory Committee Will Review Genasense as Treatment for Chronic Lymphocytic Leukemia
Mar 1, 2006	Genasense New Drug Application Accepted for Review by FDA
Dec 29, 2005	Genta Files New Drug Application for FDA Approval of Genasense Plus Chemotherapy for Patients with Advanced or Refractory Chronic Lymphocytic Leukemia
Jun 30, 2005	Genta Initiates New Drug Application for Genasense in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
May 13, 2004	Genta Announces Withdrawal of New Drug Application for Genasense in Melanoma
May 3, 2004	FDA Advisory Committee Reviews Genasense For Use in Advanced Melanoma
Apr 20, 2004	Genta and Aventis Announce Genasense Expanded Access Program for Patients with Advanced Melanoma
Feb 6, 2004	Aventis and Genta Announce FDA Acceptance and Priority Review of New Drug Application for Genasense in Advanced Melanoma

Further information

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