FLASCO

FDA approval for Neratinib to Treat HER2-Positive Metastatic Breast Cancer

  • Katrina Williams
  • March 23, 2020

Great news!  Puma Biotechnology received U.S. FDA approval for Neratinib to Treat HER2-Positive Metastatic Breast Cancer.  The sNDA approval was based on results of the Phase III NALA trial, a randomized controlled trial of neratinib plus capecitabine in patients with HER2-positive metastatic breast cancer who have received two or more prior anti-HER2-based regimens.

Adam M. Brufsky, MD, Ph.D., of Magee-Womens Hospital and the Hillman Cancer Center at the University of Pittsburgh Medical Center, added, “Together with the NALA investigators around the world, I am pleased to see the FDA approval of Neratinib for the treatment of advanced HER2-positive metastatic breast cancer. This approval is based on data from the NALA trial, which we presented at ASCO last year, demonstrating that neratinib in combination with capecitabine offers a significant improvement over currently available therapies in this heavily pretreated patient population and can be added to Neratinib’s established role in the treatment of early breast cancer.”

Neratinib is approved for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, following adjuvant trastuzumab-based therapy. In Europe, Neratinib is approved for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy.  Neratinib has also received approval for use in the extended adjuvant setting in Canada, Australia, Hong Kong, Singapore, Argentina and Switzerland.

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