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Puma's Likely Neratinib EU Knockback May Be Temporary

 
• By John Davis

A positive opinion on the marketing application for Puma's neratinib in the EU is unlikely next month after a recent discussion with regulators failed to satisfy risk-benefit concerns, but more data on controlling diarrhea are expected shortly.

Scales of Justice
The risks and benefits of neratinib are being weighed • Source: Shutterstock

Puma Biotechnology Inc.'s announcement on Jan. 23 that its new anticancer kinase inhibitor and lead product, neratinib, was unlikely to receive a positive opinion from the EU's top advisory panel, the Committee for Medicinal Products for Human Use (CHMP) came as a surprise to commentators and showed, once again, that regulatory approval in one major market may not automatically translate into approval in another.

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