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Nerlynx FDA Approval History

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

DateArticle
Feb 26, 2020Approval Puma Biotechnology Receives U.S. FDA Approval of Supplemental New Drug Application for Neratinib to Treat HER2-Positive Metastatic Breast Cancer
Jul 17, 2017Approval FDA Approves Nerlynx (neratinib) for Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer
May 24, 2017Puma Biotechnology Receives FDA Advisory Committee Support for Neratinib
Apr 17, 2017Puma Biotechnology Announces FDA Advisory Committee to Review Neratinib for the Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer
Sep 20, 2016Puma Biotechnology Announces FDA Acceptance of NDA for PB272 (Neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer
Jul 21, 2016Puma Biotechnology Submits New Drug Application for PB272 (Neratinib) to FDA for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

Further information

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