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Puma's Neratinib Gets CHMP Turnaround But Slow EU Uptake Expected

 
• By Jo Shorthouse

Puma Biotech has proven to be the cat with nine lives after its HER2+ breast cancer treatment neratinib received a u-turn from CHMP, granting it a positive trend vote. But even if final marketing approval is granted this year, European prospects don’t necessarily follow.

U turn
CHMP has reversed its negative trend vote for neratinib

In an unusual move, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has changed its mind on the merits of a product that it had originally said should not be approved for sale in the EU.

The beneficiary is Puma Biotechnology Inc

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