Medication Guide App

Palbociclib Approval Status

  • FDA approved: No
  • Generic name: palbociclib
  • Company: Pfizer Inc.
  • Treatment for: Breast Cancer

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

FDA Approval Status for palbociclib

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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