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Ribociclib - Novartis Oncology

Drug Profile

Ribociclib - Novartis Oncology

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

Latest Information Update: 25 Nov 2019

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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; Gynecologic Oncology Group; Hadassah Medical Organization; Mayo Clinic; National Cancer Institute (USA); Novartis; 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; Peritoneal cancer
  • Phase I/II Liposarcoma; Pancreatic cancer
  • Phase I Lymphoma; Non-small cell lung cancer; Soft tissue sarcoma; Solid tumours
  • Discontinued Endometrial cancer; Fallopian tube cancer; Glioma; Head and neck cancer; Liver cancer; Malignant melanoma; Meningioma; Neuroblastoma; Neuroendocrine tumours; Prostate cancer; Rhabdoid tumour; Teratoma

Most Recent Events

  • 11 Nov 2019 The Scottish Medicines Consortium recommends Ribociclib for Breast cancer (Combination therapy, Late-stage disease, Metastatic disease) in Scotland
  • 29 Sep 2019 Updated interim efficacy and adverse events data from a the phase III MONALEESA-3 trial in Breast cancer released by Novartis
  • 30 Jul 2019 Phase-I clinical trials in Solid tumours (Combination therapy, Late-stage disease, Second-line therapy or greater) in Belgium, Singapore (PO, Capsule) (NCT04000529)
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