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# Nerlynx sNDA for 3rd-line HER2 Breast Cancer
- URL: https://www.fdaweb.com/nerlynx-snda-for-3rd-line-her2-breast-cancer/
- Published: 2019-09-11T12:00:00.000Z
- Updated: 2026-09-15T01:49:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144983

FDA has accepted for review a Puma Biotechnology supplemental NDA for Nerlynx (neratinib) in combination with capecitabine for treating patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed therapy. FDA has set a late 4/2020 user fee review action date, and it is not currently planning to hold an advisory committee meeting to discuss the submission, according to the company.

The sNDA is based on data from the Phase 3 NALA trial, a randomized controlled trial of neratinib plus capecitabine versus Tykerb (lapatinib) plus capecitabine in patients with third-line HER2-positive metastatic breast cancer.

Neratinib was originally approved 7/2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy.