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Arzerra gets label expansion

  • The FDA approves Glaxo (GSK) and Genmab's (GNMSF) monoclonal antibody Arzerra (ofatumumab) as a first-line therapy for patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
  • "Arzerra is the only therapeutic CD20 antibody approved in combination with chlorambucil for first-line CLL and as a monotherapy for CLL refractory to fludarabine and alemtuzumab," says Jan de Winkel, Ph.D., Genmab's CEO.
  • In the Phase 3 COMPLEMENT 1 clinical trial the ofatumumab plus chlorambucil group's progression-free survival (PFS) was 22.4 months compared to 13.1 months for the chlorambucil alone group.
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