NDAORALTABLET
Approved
Jul 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
NERLYNX (neratinib) by Puma Biotechnology is (egfr), her2, and her4. Approved for breast cancer. First approved in 2017.
Drug data last refreshed 22h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NERLYNX (neratinib) is an oral tyrosine kinase inhibitor approved in July 2017 for metastatic HER2-positive breast cancer in patients who have received one or more prior anti-HER2 regimens. The drug works by irreversibly inhibiting EGFR, HER2, and HER4 signaling, reducing downstream MAPK and AKT pathway activation to suppress tumor growth. It represents a targeted therapy option for heavily pretreated HER2-positive disease and demonstrates activity in cell lines expressing HER2 and EGFR.
$0.0BPart D
5.2 years to LOEMechanism 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 (1)
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 May 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
36 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.