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Lorlatinib - Pfizer

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Drug Profile

Lorlatinib - Pfizer

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

Latest Information Update: 11 Apr 2025

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At a glance

  • Originator Pfizer
  • Developer CStone Pharmaceuticals; 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

  • Marketed Non-small cell lung cancer
  • Phase I Neuroblastoma

Most Recent Events

  • 11 Apr 2025 Intergroupe Francophone de Cancerologie Thoracique completes the phase II ORAKLE trial for Non small cell lung cancer (Metastatic disease, Late-stage disease, Monotherapy, Second-line therapy or greater) in France (EudraCT 2019-002230-37) (NCT04111705)
  • 21 Oct 2024 Pfizer completes a phase III trial in Non-small cell lung cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO) (NCT03909971)
  • 07 Sep 2024 Efficacy and adverse event data from Phase-II clinical trials in Non-small cell lung cancer presented at the 25th World Conference on Lung Cancer (WCLC-2024)

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