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Outline
What is the generic name?
OFATUMUMAB
What is the Trade Name for OFATUMUMAB?
ARZERRA
What are the Indications for OFATUMUMAB?
- 1 INDICATIONS AND USAGE Chronic Lymphocytic Leukemia (CLL) ARZERRA (ofatumumab) is indicated: in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate [see Clinical Studies (14.1)] in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL [see Clinical Studies (14.2)] for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL [see Clinical Studies (14.3)] for the treatment of patients with CLL refractory to fludarabine and alemtuzumab [see Clinical Studies (14.4)] ARZERRA (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of chronic lymphocytic leukemia (CLL) ( 1 ): in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL. 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.
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References: https://open.fda.gov/
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