Drug Profile


Alternative Names: Kisqali; LEE-011

Latest Information Update: 21 Mar 2017

Price : $50

At a glance

  • Originator Astex Therapeutics
  • Developer Cincinnati Children's Hospital Medical Center; Cliniques Universitaires Saint Luc; 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
  • 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.

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 20 Mar 2017 Novartis Pharmaceuticals plans the phase III EarLEE-2 trial for Breast cancer (Adjunctive treatment, First-line therapy) (PO, Tablet) (NCT03081234)
  • 17 Mar 2017 Launched for Breast cancer (Locally recurrent, Metastatic disease, Late-stage disease, First-line therapy, Combination therapy) in USA (PO) - First global launch
  • 16 Mar 2017 Ribociclib is still in phase I trials for Neuroblastoma (In adolescents, In children) in France, United Kingdom and USA (NCT01747876) (Novartis Oncology pipeline, March 2017)
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