Puma wins a big round in fight for neratinib OK as experts offer a crucial thumbs up
Puma Biotechnology $PBYI won a crucial vote in favor of its experimental breast cancer drug neratinib, with a majority of outside experts offering the FDA a thumbs-up vote in favor of approval as an extended adjuvant treatment.
On the key question of whether the risk/benefit profile of neratinib warranted an approval, the panel voted twelve to four in favor of the drug. But the support came with plenty of caveats about the narrow benefit the data demonstrated and questions about the drug’s often harsh impact on patients. Several panel members called on the FDA to narrow the approval to a smaller set of patients most likely to benefit.
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