U.S. License Holder:

Novartis

Date of License:

October-26-2009 / August-20-2020

FDA-Approved Indications

ARZERRA (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated:

In combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate;

For extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL;

For the treatment of patients with CLL refractory to fludarabine and alemtuzumab.

KESIMPTA (ofatumumab) is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.