Nerlynx FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 28, 2021.
FDA Approved: Yes (First approved July 17, 2017)
Brand name: Nerlynx
Generic name: neratinib
Dosage form: Tablets
Company: Puma Biotechnology, Inc.
Treatment for: Breast Cancer
Nerlynx (neratinib) is a tyrosine 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.
- 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.
Development timeline for Nerlynx
Further information
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