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Ceritinib - Novartis

Drug Profile

Ceritinib - Novartis

Alternative Names: LDK-378; NVP-LDK 378; NVP-LDK378-NX; Zykadia

Latest Information Update: 07 Aug 2019

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At a glance

  • Originator Novartis
  • Developer H. Lee Moffitt Cancer Center and Research Institute; Novartis; University of Texas Southwestern Medical Center
  • Class Antineoplastics; Diamines; Piperidines; Pyrimidines; Small molecules; Sulfones
  • Mechanism of Action Anaplastic lymphoma kinase 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

  • Marketed Non-small cell lung cancer
  • Phase II Gastrointestinal cancer; Haematological malignancies; Malignant melanoma; Solid tumours; Thyroid cancer

Most Recent Events

  • 26 Apr 2019 Novartis completes a phase I trial for Solid tumours (in infants, children and adolescents) in Australia, Canada, France, Germany, Italy, Netherlands, Spain, the UK, and South Korea and USA (NCT01742286) (EudraCT2012-002074-31)
  • 21 Feb 2019 The Pharmaceuticals and Medical Devices Agency recommends manufacturing and marketing approval for dosage of ceritinib capsules for the treatment of Small cell lung cancer
  • 14 Feb 2019 Novartis completes the phase II ASCEND-7 trial in Non-small cell lung cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) in Australia, Belgium, Canada, Germany, France, Italy, New Zealand, Russia, Spain, South Korea, Singapore, Taiwan, Turkey, United Kingdom, USA (PO) (NCT02336451)
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