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 ID: 814616
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Product PipelineNeratinib across the breast cancer therapy spectrum
Phase IPhase IIPhase IIIRegistrationApprovalHER2+ Breast CancerExtended adjuvantNeratinib monotherapyMetastaticMonotherapy or combination therapyMetastatic w/ brain metsMonotherapy or combination therapyNeoadjuvantCombination with standard therapyHER2-mutant Breast Cancer/Solid TumorsMetastaticNeratinib (± fulvestrant in MBC)
NSABP FB-7
NALA (Phase III 3
rd Line HER2+ MBC)
FB-10: T-DM1 + neratinib
NEfERTT (Phase II HER2+MBC)
SUMMIT (Basket Trial)
Phase II trial (WashU)
EAP/MAP
CONTROL
ExteNET (Phase III HER2+ EBC)
I-SPY 2
NSABP FB-7
TBCRC-022
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NDA filed 07/16
MAA filed 06/16