Genmab gets US FDA approval of Arzerra to treat CLL

20 January 2016

Biotech firm Genmab (Nasdaq Copenhagen: GEN) says that the US Food and Drug Administration has approved a supplemental Biologics License Application (sBLA) for the use of Arzerra (ofatumumab) for extended treatment of chronic lymphocytic leukemia (CLL).

The application was submitted by Novartis (NOVN: VX) under the ofatumumab collaboration between the two companies.

The FDA approval is based on data from an interim analysis from a Phase III study, 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.

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