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# Oncologic Panel to Review Puma NDA for Breast Cancer
- URL: https://www.fdaweb.com/oncologic-panel-to-review-puma-nda-for-breast-cancer/
- Published: 2017-04-17T12:00:00.000Z
- Updated: 2026-09-14T22:18:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138465

FDA has scheduled a 5/24 Oncologic Drugs Advisory Committee meeting to review a Puma Biotechnology NDA for neratinib, an investigational therapy for the extended adjuvant treatment for early stage HER2-positive breast cancer in patients previously treated with a trastuzumab containing regimen. The submission is based on results from both the Phase 3 ExteNET trial in extended adjuvant early stage HER2-positive breast cancer and the Phase 2 CONTROL trial in a similar patient population. The NDA was accepted for review 9/20/2016.