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Nerlynx 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, Adjuvant

Nerlynx (neratinib) is a tyrosine kinase inhibitor for the extended adjuvant treatment of early-stage HER2-positive breast cancer.

Development History and FDA Approval Process for Nerlynx

DateArticle
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
Mar 10, 2015Puma Biotechnology Initiates Phase II Trial of PB272 in Early Stage HER2-Positive Breast Cancer
May 17, 2012Puma Biotechnology to Present Clinical Data on PB272 at ASCO 2012 Annual Meeting
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

Further information

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