Lorlatinib - Pfizer

Drug Profile

Lorlatinib - Pfizer

Alternative Names: [14C]Lorlatinib; [14C]PF-06463922; PF-06463922; PF-6463922

Latest Information Update: 06 Aug 2018

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At a glance

  • Originator Pfizer
  • Developer New Approaches to Neuroblastoma Therapy Consortium; Pfizer; The EVAN Foundation; University of Southern California
  • Class Antineoplastics; Aza compounds; Benzoxazines; Nitriles; Pyrazoles; Pyridines; Small molecules
  • Mechanism of Action Anaplastic lymphoma kinase inhibitors; ROS1-protein-inhibitors
  • Orphan Drug Status

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

    Yes - Non-small cell lung cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Non-small cell lung cancer
  • Phase II Lymphoma
  • Phase I Neuroblastoma

Most Recent Events

  • 02 Aug 2018 National Cancer Center plans a phase II trial for Non small Cell Lung Cancer (Late-stage disease) in December 2018 , (NCT03612154)
  • 31 Jul 2018 The US FDA extends PDUFA action date to November 2018 for lorlatinib for Non-small cell lung cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater)
  • 30 Jul 2018 The US FDA extends review period for NDA for Non small cell lung cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) by three months
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