Nerlynx
Nerlynx ingredients
| Active ingredient | Strength |
|---|---|
| Neratinib Maleate Anhydrous | 40 mg/1 |
What Nerlynx is used for
The FDA lists the approved uses on the official label (below). In the EU, neratinib is approved as Nerlynx for:
Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Nerlynx
- Generic name
- Neratinib
- Made by
- Puma Biotechnology, Inc.
- Forms
- Tablet
- Given
- Oral
- Drug class
- Kinase Inhibitor
- FDA approval
- New drug application (NDA) NDA208051
- On the US market since
- 2017
Official information
- Nerlynx prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Neratinib)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Nerlynx?
Nerlynx (Neratinib) is a cancer medicine made by Puma Biotechnology, Inc., approved by the US FDA.
What are the ingredients of Nerlynx?
Nerlynx contains Neratinib Maleate Anhydrous (40 mg/1).
Is Nerlynx approved in Europe?
The same active substance is approved in the EU as Nerlynx.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA