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Ibrance FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 7, 2020.

FDA Approved: Yes (First approved February 3, 2015)
Brand name: Ibrance
Generic name: palbociclib
Dosage form: Capsules and Tablets
Company: Pfizer Inc.
Treatment for: Breast Cancer

Ibrance (palbociclib) is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:

  • an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or
  • fulvestrant in patients with disease progression following endocrine therapy.

Development timeline for Ibrance

Apr  4, 2019Approval FDA Approves Ibrance (palbociclib) for the Treatment of Men with HR+, HER2- Metastatic Breast Cancer
Mar 31, 2017Approval Ibrance (palbociclib) Receives FDA Regular Approval and Expanded Indication for First-Line HR+, HER2- Metastatic Breast Cancer
Feb 19, 2016Approval Pfizer Receives Expanded FDA Approval For Ibrance (palbociclib) In HR+, HER2- Metastatic Breast Cancer
Feb  3, 2015Approval FDA Approves Ibrance (palbociclib) for Postmenopausal Women with Advanced Breast Cancer
Jan  8, 2015Pfizer Provides Update on Ibrance (palbociclib)
Dec 15, 2014Pfizer Announces Palbociclib PALOMA-1 Data Published in The Lancet Oncology
Oct 13, 2014Pfizer Announces FDA Acceptance Of Palbociclib New Drug Application With Priority Review
Aug 21, 2014Palbociclib Expanded Access Program Now Open To Eligible U.S. Patients With HR+, HER2- Advanced Breast Cancer
Aug 18, 2014Pfizer Announces Submission of Palbociclib New Drug Application to the FDA
May 16, 2014Pfizer To Submit Palbociclib New Drug Application With FDA Based On Final Results Of PALOMA-1

Further information

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