Welcome to TheStreet's live blog of the FDA advisory panel reviewing Puma Biotechnology's (PBYI) breast cancer drug neratinib.
This live blog will follow all the action as a group of independent experts hears presentations from the FDA and Puma on the efficacy and safety of neratinib. The panel will then debate the benefits and risks of the drug before taking a vote on whether or not to recommend approval.
Puma is seeking FDA approval for neratinib as an extended adjuvant breast cancer therapy. That means treating post-surgery breast cancer patients first with one year Herceptin/chemo (standard adjuvant therapy) and then switching them to one year of neratinib.