Drug Profile


Alternative Names: Kisqali; LEE-011; LEE-011A

Latest Information Update: 21 Jun 2017

Price : $50

At a glance

  • Originator Astex Therapeutics
  • Developer Cedars-Sinai Medical Center; Cincinnati Children's Hospital Medical Center; Cliniques Universitaires Saint Luc; Georgetown University; H. Lee Moffitt Cancer Center and Research Institute; Hadassah Medical Organization; Mayo Clinic; National Cancer Institute (USA); Novartis Oncology; Roswell Park Cancer Institute; St Josephs Hospital and Medical Center; Thomas Jefferson University; University of Texas M. D. Anderson Cancer Center; University of Texas Southwestern Medical Center; Virginia Mason Research Center
  • Class Amides; Aminopyridines; Antineoplastics; Piperazines; Pyrimidines; Pyrroles; Small molecules
  • Mechanism of Action Cyclin-dependent kinase 4 inhibitors; Cyclin-dependent kinase 6 inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Breast cancer
  • Phase II Cancer
  • Phase I/II Liposarcoma; Non-small cell lung cancer; Pancreatic cancer
  • Phase I Lymphoma; Soft tissue sarcoma
  • Discontinued Endometrial cancer; Fallopian tube cancer; Glioma; Head and neck cancer; Hepatocellular carcinoma; Malignant melanoma; Meningioma; Neuroblastoma; Neuroendocrine tumours; Ovarian cancer; Peritoneal cancer; Prostate cancer; Rhabdoid tumour; Solid tumours; Teratoma

Most Recent Events

  • 02 Jun 2017 Updated two years follow up adverse events and efficacy data from the phase III MONALEESA-2 trial in Breast cancer released by Novartis
  • 09 May 2017 The US FDA approves Ribociclib tablets and Letrozole tablets combination pack for treatment of HR+/HER2- advanced or metastatic breast cancer in USA
  • 04 May 2017 Phase-I/II clinical trials in Pancreatic cancer (Metastatic disease, Second-line therapy or greater, Combination therapy) in USA (PO) (NCT02985125)
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