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, 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 |
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