Ofatumumab Granted Breakthrough Therapy Designation for Untreated CLL

Recently, on September 13 the FDA granted a Breakthrough Therapy Designation to ofatumumab (Arzerra) in combination with chlorambucil for previously untreated patients with chronic lymphocytic leukemia (CLL) who are inappropriate for fludarabine-based therapy. This designation is awarded to drugs whose preliminary clinical evidence suggests an improvement over existing therapies on one or more clinically significant endpoints, speeding the bench to beside process. The designation was granted after preliminary results from a phase 3 clinical trial involving over 400 patients was announced in May.

Ofatumumab is a monoclonal antibody that targets an epitope on the CD20 molecule that encompasses parts of the small and large extra-cellular loops. The CD20 molecule is found on over 90% of B-cell lymphomas and assorted lymphoid tumors with a B-cell origin. Ofatumumab effectively kills cancer cells by directing the body’s immune system against normal and cancerous B-cells, and attaching to the CD20 molecule located on the surface of cancerous B-cells.

In addition to the aforementioned purposes, ofatumumab is being investigated for treatment in follicular lymphoma, diffuse large B-cell lymphoma, and Waldenstrom’s Macroglobulinemia.

Currently, there are ongoing ofatumumab trials at the Weill Cornell Lymphoma Program open to patients with CLL. Additional listings of clinical trials for CLL & SLL patients can be found here.

Please stay updated with our clinical trials listings for forthcoming trials involving ofatumumab and the Cornell Lymphoma Program website for further clinical research updates.

Author: lymphomaprogram

Located on the Upper East Side of New York City, the Lymphoma Program at Weill Cornell Medical College/NewYork Presbyterian Hospital is internationally recognized for our efforts to enable patients with non-Hodgkin lymphoma, Hodgkin disease and related disorders to have the best possible clinical outcome, including cure when possible.

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