Novartis Withdraws Arzerra CLL Second-Line Use Filing in EU

Novartis has withdrawn its label extension application in Europe for use of Arzerra in combination with bendamustine for the treatment of relapsed chronic lymphocytic leukemia, following CHMP queries over a lack of comparable data.

Novartis AG has pulled its EU application for Arzerra (ofatumumab) in combination with bendamustine for the treatment of relapsed chronic lymphocytic leukemia (CLL) – a setback for the company which needs to up the drug's use in the second-line setting.

Arzerra used with bendamustine (Teva Pharmaceutical Industries Ltd; Treanda) is a new combination, but the European Medicines Agency’s scientific committee...

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