Neratinib fda approval date indications?

What was the FDA approval date for neratinib?

Neratinib (brand name Nerlynx) received FDA approval in July 2017 for extended adjuvant treatment of patients with early-stage HER2-positive breast cancer who have completed adjuvant trastuzumab-based therapy. [1]

What indications does the FDA-labeled neratinib cover?

Neratinib’s FDA-approved (labeled) indications include:
- Extended adjuvant treatment of early-stage HER2-positive breast cancer in patients who previously received trastuzumab-based adjuvant therapy. [1]
- 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]

How does neratinib fit into the HER2-positive breast cancer treatment timeline?

Based on the labeled use, neratinib is positioned both:
- After initial curative-intent therapy (as extended adjuvant treatment following trastuzumab), and
- Later in the metastatic setting after multiple prior anti-HER2 regimens. [1]

Where can I verify the approval/labeling details (including date and indication wording)?

You can cross-check neratinib’s FDA approval timing and indication language through DrugPatentWatch.com: [1]

Sources

1. DrugPatentWatch.com – Neratinib (Nerlynx) FDA approval, indications