neratinib
neratinib is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including Nerlynx. Available dosage form: tablet.
Drug Details
- Generic Name
- neratinib
- Brand Names
- Nerlynx
- Application Number
- NDA208051
- Sponsor
- Puma Biotechnology, Inc.
- NDC Codes
- 3
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- NERATINIB MALEATE ANHYDROUS
Indications and Usage
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-Stage Breast Cancer NERLYNX as a single agent is indicated for the extended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer, to follow adjuvant trastuzumab based therapy [see Clinical Studies ( 14.1 )] . 1.2 Advanced or Metastatic Breast Cancer NERLYNX in combination with capecitabine is indicated 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 [see Clinical Studies ( 14.2 )] .