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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

DateArticle
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

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