Lorlatinib: First Global Approval

Drugs. 2019 Jan;79(1):93-98. doi: 10.1007/s40265-018-1041-0.

Abstract

Lorlatinib is an oral small molecule inhibitor of anaplastic lymphoma kinase (ALK) and C-ros oncogene 1 (ROS1) kinase developed by Pfizer for the treatment of ALK-positive non-small cell lung cancer (NSCLC). Based on results from a phase I/II trial, lorlatinib received approval in Japan in September 2018 and in the USA in November 2018 for the treatment of ALK-positive NSCLC. This article summarizes the milestones in the development of lorlatinib leading to the first global approval for this indication.

Publication types

  • Review

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Aminopyridines
  • Anaplastic Lymphoma Kinase / antagonists & inhibitors*
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Child
  • Drug Approval
  • Humans
  • Japan
  • Lactams
  • Lactams, Macrocyclic* / administration & dosage
  • Lactams, Macrocyclic* / adverse effects
  • Lactams, Macrocyclic* / pharmacokinetics
  • Middle Aged
  • Protein Kinase Inhibitors* / administration & dosage
  • Protein Kinase Inhibitors* / adverse effects
  • Protein Kinase Inhibitors* / pharmacokinetics
  • Protein-Tyrosine Kinases / antagonists & inhibitors*
  • Proto-Oncogene Proteins / antagonists & inhibitors*
  • Pyrazoles
  • United States
  • United States Food and Drug Administration

Substances

  • Aminopyridines
  • Lactams
  • Lactams, Macrocyclic
  • Protein Kinase Inhibitors
  • Proto-Oncogene Proteins
  • Pyrazoles
  • Anaplastic Lymphoma Kinase
  • Protein-Tyrosine Kinases
  • ROS1 protein, human
  • lorlatinib