Ibrance FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 21, 2023.
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 used for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
- Ibrance is 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; or
- fulvestrant in patients with disease progression following endocrine therapy.
Development timeline for Ibrance
| Date | Article |
|---|
| Apr 4, 2019 | Approval FDA Approves Ibrance (palbociclib) for the Treatment of Men with HR+, HER2- Metastatic Breast Cancer |
| Mar 31, 2017 | Approval Ibrance (palbociclib) Receives FDA Regular Approval and Expanded Indication for First-Line HR+, HER2- Metastatic Breast Cancer |
| Feb 19, 2016 | Approval Pfizer Receives Expanded FDA Approval For Ibrance (palbociclib) In HR+, HER2- Metastatic Breast Cancer |
| Feb 3, 2015 | Approval FDA Approves Ibrance (palbociclib) for Postmenopausal Women with Advanced Breast Cancer |
| Jan 8, 2015 | Pfizer Provides Update on Ibrance (palbociclib) |
| Dec 15, 2014 | Pfizer Announces Palbociclib PALOMA-1 Data Published in The Lancet Oncology |
| Oct 13, 2014 | Pfizer Announces FDA Acceptance Of Palbociclib New Drug Application With Priority Review |
| Aug 21, 2014 | Palbociclib Expanded Access Program Now Open To Eligible U.S. Patients With HR+, HER2- Advanced Breast Cancer |
| Aug 18, 2014 | Pfizer Announces Submission of Palbociclib New Drug Application to the FDA |
| May 16, 2014 | Pfizer To Submit Palbociclib New Drug Application With FDA Based On Final Results Of PALOMA-1 |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
