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Nazartinib - Novartis Oncology

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Drug Profile

Nazartinib - Novartis Oncology

Alternative Names: EGF-816; EGFRmut-TKI EGF816; Nazartinib mesylate; NVP EGF816 AGA

Latest Information Update: 05 Sep 2025

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At a glance

  • Originator Novartis
  • Developer Massachusetts General Hospital; Novartis; Novartis Oncology
  • Class Antineoplastics; Azepines; Benzimidazoles; Pyridines; Small molecules
  • Mechanism of Action Epidermal growth factor receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Discontinued Non-small cell lung cancer; Solid tumours

Most Recent Events

  • 30 May 2025 Updated efficacy, adverse events and pharmacokinetics data from the phase I EATON trial in Non-small cell lung cancer presented at the 61st Annual Meeting of the American Society of Clinical Oncology (ASCO-2025)
  • 04 Mar 2025 Novartis terminates a phase-II clinical trials in Non-small cell lung cancer (Combination therapy, Late-stage disease, Recurrent) in USA (PO) due to slow accrual (NCT03292133)
  • 28 May 2023 No recent reports of development identified for phase-I development in Non-small-cell-lung-cancer(Combination therapy, First-line therapy, Late-stage disease, Metastatic disease) in Canada (PO, Capsule)

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