Palbociclib (Ibrance)

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General information

Class/mechanism: Cyclin-dependent kinase 4 and 6 inhibitor. Cyclin D1, CDK4, and CDK6 are downstream of signaling pathways which result in cellular proliferation. The use of palbociclib with antiestrogens was observed to increase growth arrest in estrogen receptor (ER)-positive breast cancer cell lines by decreasing retinoblastoma protein (Rb) phosphorylation, which resulted in reduced E2F expression and signaling. Palbociclib has been observed to cause cell cycle arrest between G1 to S phase of the cell cycle in ER-positive breast cancer cell lines.[1][2][3]
Route: PO
Extravasation: n/a

For conciseness and simplicity, currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the package insert.[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

History of changes in EMA indication

  • 2016-11-09: Initial authorization

History of changes in Health Canada indication

  • 2016-03-16: Initial notice of compliance with conditions
  • 2016-11-17: Conditions were met

History of changes in PMDA indication

  • 2017-09-27: New approval for the treatment of unresectable or recurrent breast cancer.
  • 2020-01-23: New indication in a new dosage form for the treatment of hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative inoperable or recurrent breast cancer.

Also known as

  • Code name: PD-0332991
  • Brand names: Ibrance, Lucipalb, Palbace, Palbocap, Palbocent, Palbonix