neratinib
neratinib: developed by 1 company · 11 clinical trials tracked · 1 FDA decision.
neratinib evidence translation
What we can confirm
1 FDA record · 11 tracked trials
What it means
What to watch
Prepared research question
How could neratinib → PBYI affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 1 study sponsors
Development Pipeline (1)
| Company | Phase |
|---|---|
| PUMA BIOTECHNOLOGY, INC. (PBYI) | Approved |
Clinical Trials (11)showing 10 most recent
Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial
Primary endpoint: Progression-free survival (PFS)
Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
Primary endpoint: Preoperative endocrine prognostic index score
A Phase II Study Of Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Overexpressing Gastroesophageal Cancers
Primary endpoint: Objective Response Rate (ORR)
An Open Label, Phase II Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Cancers Hoosier Cancer Research Network BRE17-141
Primary endpoint: Pathologic Complete Response (pCR)
A Phase 1/1b Clinical Trial of Niraparib and Neratinib in Advanced Solid Tumors With an Expansion Cohort in Platinum-resistant Ovarian Cancer
Primary endpoint: Phase 1: To determine the Recommended phase 2 dose (RP2D) of niraparib and neratinib in patients with advanced solid tumors
Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)
Primary endpoint: Radiographic response rate (for each drug substudy)
Phase 1/2 Study of Neratinib and Divalproex Sodium (Valproate) in Advanced Solid Tumors, With an Expansion Cohort in Ras-Mutated Cancers
Primary endpoint: Determination of Recommended Phase 2 Dose (RP2D)
A Phase 1b Study of Neratinib, Pertuzumab, and Trastuzumab With Taxol (3HT) in Metastatic and Locally Advanced Breast Cancer, and Phase II Study of 3HT Followed by AC in HER2 + Primary IBC, and Neratinib With Taxol (NT) Followed by AC in HR+ /HER2- Primary IBC
Primary endpoint: Dose-Limiting Toxicities (DLTs) During Dose Escalation
Phase Ib/II Study of Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer
Primary endpoint: Maximum Tolerated Dose (MTD)
A Phase 2 Study of Neratinib With or Without Fulvestrant in HER2-Positive, ER-Positive Metastatic Breast Cancer
Primary endpoint: Progression Free Survival
FDA Decisions1 records
Frequently asked questions
Who is developing neratinib?
neratinib is being developed by PUMA BIOTECHNOLOGY, INC..
How many clinical trials involve neratinib?
BioSniper tracks 11 clinical trials involving neratinib.
What is neratinib's latest FDA decision?
The most recent tracked FDA decision for neratinib is Approval for 1 INDICATIONS AND USAGE NERLYNX is a kinase inhibitor indicated: As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy. ( 1.1 ) In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. ( 1.2 ) 1.1 Extended Adjuvant Treatment of Early, dated July 17, 2017.