FDA approves Arzerra (ofatumumab) for recurrent or progressive chronic lymphocytic leukemia- Novartis/Genmab

January 2016-The FDA has approved a supplemental Biologics License Application (sBLA) for the use of Arzerra (ofatumumab) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). The application was submitted by Novartis under the ofatumumab collaboration between it and Genmab.

This FDA approval is based on data from an interim analysis from a Phase III study, PROLONG (OMB112517) which evaluated ofatumumab maintenance therapy versus no further treatment in patients with a complete or partial response after second or third line treatment for CLL. Patients who received ofatumumab maintenance treatment lived 14.2 months longer without their disease worsening than patients who received no further treatment. Median progression free survival (PFS) as assessed by the investigators was 29.4 months for the ofatumumab treatment arm and 15.2 months for the observation arm. There were no unexpected safety findings.