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# FDA Accepts Puma NDA for Breast Cancer Therapy
- URL: https://www.fdaweb.com/fda-accepts-puma-nda-for-breast-cancer-therapy/
- Published: 2016-09-20T12:00:00.000Z
- Updated: 2026-09-14T21:33:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136864

FDA has accepted for review a Puma Biotechnology NDA for its lead product candidate PB272 (neratinib), indicated for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin)-based therapy. The submission is based on data from the ExteNET Phase 3 study, in which treatment with neratinib resulted in a 33% risk reduction in invasive disease recurrence or death when compared with a placebo.  
  
“The two-year invasive disease-free survival (DFS) rate for the neratinib arm was 93.9% and the two-year invasive DFS rate for the placebo arm was 91.6%, the company says. “For the pre-defined subgroup of patients with hormone receptor positive disease, the results of the trial demonstrated that treatment with neratinib resulted in a 49% reduction of risk of invasive disease recurrence or death versus placebo... For the patients with hormone receptor positive disease, the two-year invasive DFS rate for the neratinib arm was 95.4% and the two-year invasive DFS rate for the placebo arm was 91.2%.”