Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that HER2-positive status confers therapeutic sensitivity to Neratinib in patients with Invasive Breast Carcinoma.

The U.S. Food and Drug Administration granted approval to neratinib for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab based therapy.

This statement is based on a regulatory approval from the Food and Drug Administration:

NERLYNX is a kinase inhibitor indicated as a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab based therapy.

Citation

Puma Biotechnology, Inc. Nerlynx (neratinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208051s009lbl.pdf. Revised June 2021. Accessed October 30, 2024.