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Ribociclib - Novartis Oncology

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Drug Profile

Ribociclib - Novartis Oncology

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

Latest Information Update: 27 Sep 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Breast cancer; HER2 negative 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

  • 27 Sep 2024 Launched for HER2-negative-breast-cancer (Adjuvant therapy, Combination therapy) in USA (PO)
  • 20 Sep 2024 The US FDA approves ribociclib tablets and letrozole tablets combination pack (Kisqali Femara Co-Pack ) for treatment of HER2-negative breast cancer (Combination therapy, Adjuvant therapy) in USA (PO)
  • 17 Sep 2024 Registered for HER2-negative-breast-cancer (Combination therapy, Adjuvant therapy) in USA (PO)

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