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FDA Breakthrough Therapy Designation: 22 And Counting

September 13, 2013

Genmab (Copenhagen, Denmark) and GlaxoSmithKline (GSK) announce on September 13, 2013, that the FDA grants orphan drug Arzerra (Ofatumumab) in combination with Chlorambucil, the coveted Breakthrough Therapy Designation (BTD). The BTD is for the treatment of patients with Chronic Lymphocytic Leukemia (CLL), who have not received prior treatment and are inappropriate for Fludarabine-based therapy. Ofatumumab is not approved or licensed anywhere in the world for use in this treatment setting.

The BTD is based on data from an international, multicenter, randomized 400 patient Phase III clinical trial for patients with previously untreated CLL. Positive results from this trial are presented in May 2013 and will also be presented at the December 2013 American Society of Hematology (ASH) Annual Meeting in New Orleans.

Ofatumumab is being investigated for use in other oncology and autoimmune diseases :

•   Follicular Lymphoma (FL)
•   Diffuse Large B-Cell Lymphoma (DLBCL)
•   Waldenstrom’s Macroglobulinemia (WM)
•   Pemphigus Vulgaris (PV)
•   Relapsing-Remitting Multiple Sclerosis (RRMS).

Regulatory events for Genmab/GSK’s Ofatumumab:

•   In 2008 in Europe, the drug receives orphan designation for CLL
•   In 2009, the FDA approves orphan drug Arzerra for CLL
•   In March 2013, Ofatumumab is approved by Japan’s Ministry of Health, Labour, and Welfare (MHLW) for relapsed/refractory CD20-positive Chronic Lymphocytic Leukemia (CLL).

What is interesting to note from the Orphan Druganaut Blog’s FDA BTD Chart :

•   Genmab receives 2 BTDs: Daratumumab and Ofatumumab
•   GSK receives 2 BTDs: Drisapersen and Ofatumumab.

Please Note: “A group of three balloons on ribbons” JPEG by AJ (Open clip Art Library image’s page) [see page for license] | Wikimedia Commons.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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