- Tomorrow is the FDA's action date (PDUFA) for its review of Novartis' (NVS -0.2%) supplemental New Drug Application (sNDA) seeking clearance of Arzerra (ofatumumab) for the maintenance treatment of chronic lymphocytic leukemia (CLL) patients who have relapsed.
- Arzerra is currently cleared in the U.S. to treat CLL patients who have not responded to fludarabine and alemtuzumab (Sanofi's LEMTRADA) and, in combination with chlorambucil, for treatment-naive CLL patients for whom fludarabine-based therapy is inappropriate.
- Novartis, by way of GlaxoSmithKline (GSK -0.6%) is commercializing ofatumumab via a collaboration agreement with Danish biotech Genmab A/S (OTCPK:GNMSF)(OTCPK:GMXAY).
- Ofatumumab is a monoclonal antibody that binds to CD20, an antigen found on the surface of CLL cells and normal B lymphocytes.
- Previously: FDA tags Genmab's ofatumumab for Priority Review for maintenance therapy for CLL (Sept. 20, 2015)
- Previously: Novartis files Arzerra sBLA for expanded use in chronic lymphocytic leukemia (July 22, 2015)
- Update: Approval issued yesterday.