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Neratinib Approved in Canada for Early-Stage HER2+ Breast Cancer

Gina Columbus @ginacolumbusonc
Published: Wednesday, Jul 17, 2019

Jonathan Ross Goodman, chief executive officer of Knight

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.

References

  1. 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.
  2. 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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