ArzerraTreatment for Chronic Lymphocytic Leukemia
Update: Arzerra (ofatumumab) Now FDA Approved - October 26, 2009
FDA Advisory Committee to Review Arzerra
FDA Advisory Committee to Review Arzerra (Ofatumumab)
Copenhagen, Denmark; May 4, 2009 - Genmab A/S announced today that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will hold a meeting on May 29, 2009 to review the Arzerra (ofatumumab) Biologics License Application (BLA) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received prior therapy.
Genmab and GlaxoSmithKline submitted the BLA in January 2009 and announced that the FDA accepted it for review in April 2009. The FDA has granted ofatumumab priority review status.
Ofatumumab is a novel, investigational, fully human monoclonal antibody that targets a membrane-proximal (close to the cell surface) small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule of B-cells. This epitope is different from the binding sites targeted by other CD20 antibodies currently available. The CD20 molecule is a key target in CLL therapy because it is expressed on most B-cells in CLL patients.
Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country.
Posted: May 2009
- Genmab Announces U.S. FDA Approval of Arzerra (ofatumumab) in Combination with Fludarabine and Cyclophosphamide for Relapsed CLL - August 31, 2016
- Genmab Announces U.S. FDA Approval of Arzerra (ofatumumab) as Extended Treatment for Recurrent or Progressive CLL - January 19, 2016
- FDA Approves Arzerra (ofatumumab) for Chronic Lymphocytic Leukemia - October 26, 2009
- FDA Extends Review of Arzerra (ofatumumab) - June 16, 2009
- GSK/Genmab Receive Favorable Recommendation for Arzerra from FDA Advisory Panel - May 29, 2009
- Arzerra (Ofatumumab) Granted Priority Review By FDA - April 3, 2009
- GlaxoSmithKline and Genmab Submit Arzerra (Ofatumumab) Application to FDA for the Treatment of Advanced Stage Blood Cancer - January 30, 2009