The FDA today agreed to review Puma Biotechnology�s $PBYI New Drug Application (NDA) seeking approval of neratinib (PB272) for the extended adjuvant cure of patients with early-stage HER2+ breast cancer who have been before treated with adjuvant trastuzumab-based therapy (Roche's Herceptin).The data backing-up the filing was generated in the Phase 3 ExteNET study which gave evidence treating patients with neratinib resulted in a 33% reduction in the risk of invasive disease recurrence or death versus placebo.