Ribociclib (Kisqali)

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General information

Class/mechanism: Cyclin-dependent kinase (CDK) 4 and 6 inhibitor. Ribociclib inhibits DNA synthesis and cancer cell growth by blocking activity of the cyclin D-CDK4/6 complex which regulates cell cycle progression and cellular proliferation by phosphorylating the retinoblastoma protein (pRb). Inhibiting pRb phosphorylation has been observed to lead to cell cycle arrest in the G1 phase.[1][2][3]
Route: PO
Extravasation: n/a

Diseases for which it is used

Patient drug information

History of changes in FDA indication

History of changes in EMA indication

  • 2017-08-22: Initial authorization

History of changes in Health Canada indication

  • 2018-06-18: Initial notice of compliance in combination with letrozole for treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as an initial endocrine-based therapy.
  • 2020-02-07: Expanded indication (details unavailable)
  • 2023-02-10: Expanded indication (details unavailable)

Also known as

  • Code names: LEE-011
  • Brand names: Kisqali, Kryxana