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Ibrance Approval History

  • FDA approved: Yes (First approved February 3rd, 2015)
  • Brand name: Ibrance
  • Generic name: palbociclib
  • Company: Pfizer Inc.
  • Treatment for: Breast Cancer

Ibrance (palbociclib) is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor for the combination treatment of ER+, HER2- metastatic breast cancer.

FDA Approval History for Ibrance

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

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