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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.

Neratinib oral tablets (Nerlynx) were approved by the US FDA in July 2017, but Puma reported on Jan. 23, 2018...

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