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# Pfizer Gains Expanded Ibrance Indication
- URL: https://www.fdaweb.com/pfizer-gains-expanded-ibrance-indication/
- Published: 2023-02-01T12:00:00.000Z
- Updated: 2026-09-14T18:14:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153680

Pfizer says it gained an expanded indication in late December for Ibrance (palbociclib) to include its use in combination with an aromatase inhibitor (AI) for treating HR+/HER2- metastatic breast cancer, regardless of menopausal status — the only CDK 4/6 inhibitor with this indication. “The approval expands on Ibrance’s existing indication for use in combination with an AI as initial endocrine-based therapy in postmenopausal women or in men, and for use with fulvestrant in patients with disease progression following endocrine therapy,” the company says in a financial [release](https://s28.q4cdn.com/781576035/files/doc%5Ffinancials/2022/q4/Q4-2022-PFE-Earnings-Release.pdf?ref=fdaweb.com). Click here to view FDA’s [approval letter](https://www.accessdata.fda.gov/drugsatfda%5Fdocs/appletter/2022/207103Orig1s015;212436Orig1s003ltr.pdf?ref=fdaweb.com) and Ibrance’s new [label](https://www.accessdata.fda.gov/drugsatfda%5Fdocs/label/2022/207103s015lbl.pdf?ref=fdaweb.com).