FDA Approves sNDA for Neratinib as Therapy for HER2-Positive Metastatic Breast Cancer

Officials from the FDA have approved a supplemental New Drug Application (sNDA) for neratinib (NERLYNX, Puma Biotechnology) in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer that have received 2 or more prior anti-HER2-based regimens in the metastatic setting.

Officials from the FDA have approved a supplemental New Drug Application (sNDA) for neratinib (NERLYNX, Puma Biotechnology) in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer that have received 2 or more prior anti-HER2-based regimens in the metastatic setting.1

Neratinib was previously approved by the FDA for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy.2

“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 NERLYNX’s established role in the treatment of early breast cancer,” said Adam M. Brufsky, MD, PhD, of Magee-Womens Hospital and the Hillman Cancer Center at the University of Pittsburgh Medical Center, in a prepared statement. 1

The phase 3 NALA trial is a randomized controlled trial of neratinib plus capecitabine in patients with HER2-positive metastatic breast cancer that have received 2 or more prior anti-HER2-based regimens.1

The most common adverse reactions of neratinib plus capecitabine arm were diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.1

REFERENCE

  • Puma Biotechnology receives US FDA approval of supplemental new drug application for neratinib to treat HER2-positive metastatic breast cancer [news release]. Los Angeles, CA; Puma Biotechnology: February 26, 2020. https://www.pumabiotechnology.com/pr20200226.html. Accessed February 26, 2020.
  • FDA approves neratinib for extended adjuvant treatment of early stage HER2-positive breast cancer. FDA. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neratinib-extended-adjuvant-treatment-early-stage-her2-positive-breast-cancer. Published July 17, 2017. Accessed February 26, 2020.