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Ribociclib - Novartis Oncology

Drug Profile

Ribociclib - Novartis Oncology

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

Latest Information Update: 30 Apr 2021

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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); National Taiwan University Hospital; 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.

    No
  • 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 Solid tumours; Squamous cell cancer
  • No development reported Lymphoma; Non-small cell lung cancer; Soft tissue sarcoma
  • 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

  • 21 Apr 2021 Translational Research in Oncology completes enrolment in the phase III NATALEE trial for Breast cancer worldwide (NCT03701334) (EudraCT2018-002998-21)
  • 01 Feb 2021 University of Texas Southwestern Medical Center and Novartis terminates a phase II trial for Liver cancer (Late-stage disease) in USA after withdrawal of support from the sponsor (NCT02524119)
  • 09 Dec 2020 Efficacy and adverse events data from a phase II trial at in Breast cancer presented at the 2020 San Antonio Breast Cancer Symposium (SABCS-2020)
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