Ribociclib - Novartis Oncology

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Drug Profile

Ribociclib - Novartis Oncology

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

Latest Information Update: 28 Mar 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; H. Lee Moffitt Cancer Center and Research Institute; 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.

    No
  • 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

  • 15 Mar 2018 Novartis withdraws the EarLEE-2 trial for Breast cancer (Adjuvant therapy) prior to enrolment, due to change in study plan (NCT03081234)
  • 20 Feb 2018 Novartis Pharmaceuticals plans the BioItaLEE phase III trial for Breast Cancer (Late-stage disease; First-line therapy) in February 2018 , (NCT03439046)
  • 20 Feb 2018 Array BioPharma completes a phase I/II trial in Malignant melanoma (Late-stage disease, Metastatic disease, Second-line therapy or greater, Combination therapy) in USA, Australia, Germany, Italy, Norway and Netherlands (PO) (NCT01781572)
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