Drug Profile


Alternative Names: EGF-816; EGFRmut-TKI EGF816

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Novartis
  • Developer Novartis; Novartis Oncology
  • Class Antineoplastics; Small molecules
  • Mechanism of Action Epidermal growth factor receptor antagonists; Protein tyrosine 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

  • Phase II Non-small cell lung cancer
  • Discontinued Solid tumours

Most Recent Events

  • 06 Nov 2017 Novartis plans a phase Ib trial for Non-small cell lung cancer (Combination therapy, Late-stage disease, Metastatic disease) in USA (CEGF816X2102; NCT03333343)
  • 28 Sep 2017 Massachusetts General Hospital and Novartis plan a phase II trial for Non-small cell lung cancer (Combination therapy, Late-stage disease) in USA (NCT03292133)
  • 27 Jan 2017 Discontinued - Phase-I for Solid tumours (Combination therapy, Late-stage disease, Metastatic disease) in Belgium (PO) (Novartis 20-F filed in 2017)
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