1. Product Pipeline Neratinib across the breast cancer therapy spectrum
Phase I
Phase II
Phase III
Registration
Approval
HER2+ Breast Cancer
Extended adjuvant
Neratinib monotherapy
Metastatic
Monotherapy or combination therapy
Metastatic w/ brain mets
Neoadjuvant
Combination with standard therapy
US - 7/17/17
HER2-mutant Breast Cancer/Solid Tumors
Neratinib (± fulvestrant in MBC)
NDA filed 07/16
MAA filed 06/16
CONTROL
ExteNET (Phase III HER2+ EBC)
EAP/MAP
NALA (Phase III 3rd Line HER2+ MBC)
FB-10: T-DM1 + neratinib
NEfERTT (Phase II HER2+MBC)
NSABP FB-7
TBCRC-022
I-SPY 2
NSABP FB-7
SUMMIT (Basket Trial)
Phase II trial (WashU)
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