Drug Profile


Alternative Names: NMS-E628; RXDX-101

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Nerviano Medical Sciences
  • Developer Ignyta; Nerviano Medical Sciences
  • Class Antineoplastics; Benzamides; Indazoles; Piperazines; Pyrans; Small molecules
  • Mechanism of Action Anaplastic lymphoma kinase inhibitors; ROS1-protein-inhibitors; TrkA receptor antagonists; TrkB receptor antagonists; TrkC receptor antagonists
  • Orphan Drug Status

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

    Yes - Neuroblastoma; Non-small cell lung cancer; Solid tumours; Colorectal cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Colorectal cancer; Non-small cell lung cancer; Solid tumours
  • Phase I Neuroblastoma
  • Preclinical Acute myeloid leukaemia

Most Recent Events

  • 10 Jul 2017 Entrectinib receives Orphan Drug status for Solid tumours (NTRK fusion-positive) in USA
  • 15 May 2017 Entrectinib receives Breakthrough Therapy status for Solid tumours (Late-stage disease, Metastatic disease, Second-line therapy or greater) in USA
  • 27 Apr 2017 Ignyta announces intention to file NDA with the US FDA for Solid tumours (TRK tissue agnostic) and Non-small cell lung cancer (ROS1 fusion positive) in 2018
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