NDAORALTABLET
Approved
Jul 2017
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
5/8 — Partial
NERLYNX (neratinib) by Puma Biotechnology is (egfr), her2, and her4. First approved in 2017.
Drug data last refreshed 10h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NERLYNX (neratinib) is an oral small-molecule tyrosine kinase inhibitor that irreversibly targets EGFR, HER2, and HER4 to inhibit downstream signaling pathways and tumor growth. It is indicated for HER2-expressing cancers, particularly breast cancer, and demonstrates in vivo efficacy in xenograft models. The drug represents a key option in the HER2-targeted oncology landscape.
$37MPart D
Peak4.8 years to LOEThe product is at peak commercial maturity with modest Medicare spending (~$37M); field teams are established but face growing competitive pressure (8/10), signaling potential team consolidation ahead of LOE.
Mechanism of Action
(EGFR), HER2, and HER4. In vitro , neratinib reduces EGFR and HER2 autophosphorylation, downstream MAPK and AKT signaling pathways, and showed antitumor activity in EGFR and/or HER2 expressing carcinoma cell lines. Neratinib human metabolites M3, M6, M7 and M11 inhibited the activity of EGFR, HER2,…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Neratinib Tablets Monotherapy for Advanced Solid Tumors With HER2 Mutations
Started Aug 2024
60 enrolled
Advanced Solid Tumor
Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
Started Jun 2024
30 enrolled
Anatomic Stage I Breast CancerAnatomic Stage II Breast CancerAnatomic Stage III Breast Cancer+1 more
Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer
Started Jan 2024
8 enrolled
GastroEsophageal CancerGastric Cancer
Neratinib Tablets in the Treatment of Advanced NSCLC With Rare EGFR Mutations
Started Nov 2023
42 enrolled
NSCLC
Fulvestrant + Neratinib In Breast Cancer
Started Jul 2023
0Stage IV (Metastatic) Breast CancerMetastatic Breast CancerER Positive Breast Cancer+3 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.