FDA grants priority review status to Arzerra combination

18 May 2016

The US Food and Drug Administration has granted Priority Review to the supplemental Biologics License Application (sBLA) for Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide (FC) for to treat relapsed chronic lymphocytic leukemia (CLL) patients.

The application was submitted to the FDA by Novartis (NOVN: VX) in March 2016 under the ofatumumab collaboration with Genmab (OMX: GEN).

Priority Review is an FDA designation for drugs that treat serious conditions and which may provide a significant improvement in safety or efficacy compared to existing standard therapies.

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