Ribociclib - Novartis Oncology

Drug Profile

Ribociclib - Novartis Oncology

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

Latest Information Update: 25 Jul 2018

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At a glance

  • Originator Astex Therapeutics
  • Developer Array BioPharma; Cedars-Sinai Medical Center; Cincinnati Children's Hospital Medical Center; Cliniques Universitaires Saint Luc; Georgetown University; 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; Ovarian 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; Peritoneal cancer; Prostate cancer; Rhabdoid tumour; Solid tumours; Teratoma

Most Recent Events

  • 19 Jul 2018 Launched for Breast cancer (Second-line therapy or greater, Metastatic disease, Combination therapy, Late-stage disease) in USA (PO)
  • 18 Jul 2018 Registered for Breast cancer (Late-stage disease, Combination therapy, Second-line therapy or greater, Metastatic disease) in USA (PO)
  • 18 Jul 2018 FDA approves ribociclib for treatment of Pre/Perimenopausal Breast cancer (Combination therapy, Late-stage-disease, Metastatic disease, First-line therapy) in USA
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