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# FDA Approves Pfizer Ibrance Expanded Use
- URL: https://www.fdaweb.com/fda-approves-pfizer-ibrance-expanded-use/
- Published: 2016-02-19T12:00:00.000Z
- Updated: 2026-09-15T02:37:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134836

> FDA has approved an expanded use for Pfizer’s Ibrance (palbociclib) 125mg capsules — treating hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy. Approval was based on data from the Phase 3 PALOMA-3 trial in pre-, peri- and post-menopausal women with HR+, HER2- metastatic breast cancer whose disease progressed on or after prior endocrine therapy in the adjuvant or metastatic setting. Ibrance first was approved 2/2015 for treating HR+, HER2- advanced or metastatic breast cancer in combination with letrozole as initial endocrine-based therapy in postmenopausal women.