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
|Jul 17, 2017|| FDA Approves Nerlynx (neratinib) for Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer|
|May 24, 2017||Puma Biotechnology Receives FDA Advisory Committee Support for Neratinib|
|Apr 17, 2017||Puma Biotechnology Announces FDA Advisory Committee to Review Neratinib for the Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer|
|Sep 20, 2016||Puma Biotechnology Announces FDA Acceptance of NDA for PB272 (Neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer|
|Jul 21, 2016||Puma Biotechnology Submits New Drug Application for PB272 (Neratinib) to FDA for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer|
|Mar 10, 2015||Puma Biotechnology Initiates Phase II Trial of PB272 in Early Stage HER2-Positive Breast Cancer|
|May 17, 2012||Puma Biotechnology to Present Clinical Data on PB272 at ASCO 2012 Annual Meeting|
|Dec 9, 2011||Puma Biotechnology Announces Positive PB272 (Neratinib) Phase II Data at CTRC-AACR San Antonio Breast Cancer Symposium|
|Dec 14, 2009||Pfizer Announces Neratinib Data In HER2 Positive Breast Cancer|
|May 29, 2009||New 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, 2008||Wyeth Announces Positive Data from Phase 2 Study of Neratinib in Advanced HER-2-Positive Breast Cancer|
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