Drug Profile


Alternative Names: LEE-011

Latest Information Update: 22 Feb 2017

Price : $50

At a glance

  • Originator Astex Therapeutics
  • Developer Cincinnati Children's Hospital Medical Center; Cliniques Universitaires Saint Luc; Columbia University; 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
  • 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

  • Preregistration Breast cancer
  • Phase II Cancer; Endometrial cancer; Fallopian tube cancer; Gastrointestinal cancer; Glioma; Hepatocellular carcinoma; Malignant melanoma; Meningioma; Ovarian cancer; Peritoneal cancer; Teratoma
  • Phase I/II Liposarcoma; Non-small cell lung cancer; Prostate cancer; Solid tumours
  • Phase I Head and neck cancer; Lymphoma
  • Phase Unknown Soft tissue sarcoma
  • No development reported Neuroblastoma; Renal cancer

Most Recent Events

  • 21 Feb 2017 University of Michigan Cancer Center plans a phase I trial for Ovarian cancer (Recurrent) in USA NCT03056833)
  • 08 Feb 2017 Novartis Pharmaceuticals plans a phase III trial for Breast cancer (Combination therapy, Locally recurrent, Late-stage disease, Metastatic disease) in USA (PO) (NCT03050398)
  • 02 Jan 2017 M.D. Anderson Cancer Center and Novartis plan a phase II trial for Endometrial cancer (Recurrent, Combination therapy, Second-line therapy or greater, Late-stage disease) in USA (NCT03008408)
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