Ceritinib

Drug Profile

Ceritinib

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

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Novartis
  • Developer 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.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 23 Feb 2017 Preregistration for Non-small cell lung cancer (First-line therapy, Late-stage disease) in USA (PO)
  • 23 Feb 2017 Ceritinib receives Breakthrough Therapy status for Non-small cell lung cancer (First-line therapy, Metastatic disease) in USA
  • 23 Feb 2017 The US FDA accepts sNDA for ceritinib for Non-small cell lung cancer (First line therapy, Metastatic disease) for Priority review
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