Skip to Content

Neratinib Approval Status

Neratinib is a potent irreversible tyrosine kinase inhibitor in development for the extended adjuvant treatment of HER2-positive early stage breast cancer.

Development Status and FDA Approval Process for neratinib

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
Dec  9, 2011Puma Biotechnology Announces Positive PB272 (Neratinib) Phase II Data at CTRC-AACR San Antonio Breast Cancer Symposium
Dec 14, 2009Pfizer Announces Neratinib Data In HER2 Positive Breast Cancer
May 29, 2009New Preliminary Data from Two Studies Show Clinical Activity of Neratinib in Combination with Trastuzumab and in Combination with Paclitaxel in Advanced HER-2 Positive Breast Cancer
Dec 12, 2008Wyeth Announces Positive Data from Phase 2 Study of Neratinib in Advanced HER-2-Positive Breast Cancer

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.