Jonathan Ross Goodman
Health Canada has approved neratinib (Nerlynx) for the extended adjuvant treatment of patients with early-stage, hormone receptor (HR)–positive, HER2-overexpressed/amplified breast cancer within 1 year after completing trastuzumab (Herceptin)-based adjuvant therapy.1
The FDA approved neratinib for the extended adjuvant treatment of patients with early-stage, HER2-positive breast cancer following postoperative trastuzumab in July 2017.
- Puma Biotechnology’s Licensing Partner Knight Therapeutics Receives Regulatory Approval from Health Canada to Commercialize NERLYNX (neratinib) for Extended Adjuvant Treatment of Hormone Receptor Positive, HER2-Positive Early Stage Breast Cancer. Puma Biotechnology. Published July 16, 2019. https://bit.ly/30Ahyq5. Accessed July 16, 2019.
- Martin M, Holmes FA, Ejlertsen B, et al. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18(12):1688-16700. doi: 10.1016/S1470-2045(17)30717-9.
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