In this NDA, the Applicant submitte

In this NDA, the Applicant submitted safety data from Study 3004, a Phase 3 trial of neratinib vs. placebo, with the original submission. The entire safety analysis set supporting the approval of neratinib is comprised of 31 studies in 3,252 people, including 12 studies in healthy volunteers (n=357); 8 studies of neratinib monotherapy (4 in breast cancer and 4 in other solid tumors; n = 2,079), 3 studies of neratinib in combination therapy in breast cancer and 8 studies of neratinib combination therapy in other solid tumors (n = 816). There were no clinical holds for safety during the development of neratinib.