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Novartis Withdraws Arzerra CLL Second-Line Use Filing in EU

 
• By Lucie Ellis-Taitt

Novartis has withdrawn its label extension application in Europe for use of Arzerra in combination with bendamustine for the treatment of relapsed chronic lymphocytic leukemia,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 – the Committee for Medicinal Products for Human Use –...

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