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Ribociclib - Novartis Oncology

Drug Profile

Ribociclib - Novartis Oncology

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

Latest Information Update: 08 May 2024

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At a glance

  • Originator Astex Therapeutics; Mount Sinai Health System
  • Developer Array BioPharma; Cedars-Sinai Medical Center; Cincinnati Children's Hospital Medical Center; Cliniques Universitaires Saint Luc; Dana-Farber Cancer Institute; Georgetown University; Gynecologic Oncology Group; Hadassah Medical Organization; Mayo Clinic; Memorial Sloan-Kettering Cancer Center; National Cancer Institute (USA); National Taiwan University Hospital; Novartis; Novartis Oncology; Roswell Park Cancer Institute; Seagen; SOLTI Breast Cancer Research Group; St Josephs Hospital and Medical Center; Thomas Jefferson University; UNICANCER; 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; Oligodendrocyte transcription factor 2 inhibitors; Type 3 fibroblast growth factor receptor antagonists
  • 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; Malignant melanoma; Neuroendocrine tumours; Ovarian cancer; Peritoneal cancer
  • Phase I/II Liposarcoma; Neuroblastoma; Pancreatic cancer; Triple negative breast cancer
  • Phase I Glioma; Medulloblastoma; Rhabdoid tumour; Rhabdomyosarcoma
  • No development reported Lymphoma; Non-small cell lung cancer; Soft tissue sarcoma; Solid tumours; Squamous cell cancer
  • Discontinued Endometrial cancer; Fallopian tube cancer; Head and neck cancer; Liver cancer; Meningioma; Prostate cancer; Teratoma

Most Recent Events

  • 24 Apr 2024 Novartis Pharmaceutical suspends a phase IIIb Adjuvant WIDER trial Breast cancer (Combination therapy, Adjuvant therapy, Early-stage disease) in Australia (PO) due to manufacturing adjustments (NCT05827081)
  • 10 Apr 2024 Phase-III clinical trials in Breast cancer (Combination therapy, Adjuvant therapy, Early-stage disease) in Australia (PO) (NCT05827081)
  • 21 Mar 2024 Updated efficacy data from the phase III NATALEE trial in Breast Cancer released by Novartis
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