Ceritinib - Novartis

Drug Profile

Ceritinib - Novartis

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

Latest Information Update: 06 Aug 2018

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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

  • 18 Jun 2018 Phase-II clinical trials in Malignant melanoma (Inoperable/Unresectable, Second-line therapy or greater, Late-stage disease) in USA (PO) (NCT03501368)
  • 02 Apr 2018 University of Colorado and Novartis terminate a phase II trial in Gastrointestinal cancer (Inoperable/Unresectable, Late-stage disease, Second-line therapy or greater) in USA due to low patient enrolment (NCT02638909)
  • 24 Jan 2018 National Institute for Health and Clinical Excellence (NICE) approves ceritinib for ALK-positive non-small-cell lung cancer (First-line therapy; late-stage disease)
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