MedPath

lorlatinib

Generic Name
lorlatinib
Brand Names
Lorbrena, Lorviqua
Drug Type
Small Molecule
Chemical Formula
C21H19FN6O2
CAS Number
1454846-35-5
Unique Ingredient Identifier
OSP71S83EU

Overview

Lorlatinib is a third-generation ALK tyrosine kinase inhibitor (TKI) for patients with ALK-positive metastatic non-small cell lung cancer which was first approved by the US FDA in November of 2018. It was subsequently approved by the EMA in 2019 for the treatment of select patients with previously treated advanced ALK-positive non-small cell lung cancer, followed by an expanded approval in 2022 to include lorlatinib as a first-line treatment option in advanced ALK-positive NSCLC.

Background

Lorlatinib is a third-generation ALK tyrosine kinase inhibitor (TKI) for patients with ALK-positive metastatic non-small cell lung cancer which was first approved by the US FDA in November of 2018. It was subsequently approved by the EMA in 2019 for the treatment of select patients with previously treated advanced ALK-positive non-small cell lung cancer, followed by an expanded approval in 2022 to include lorlatinib as a first-line treatment option in advanced ALK-positive NSCLC.

Indication

Lorlatinib is indicated for the treatment of adult patients with ALK-positive metastatic non-small cell lung cancer (NSCLC). In the EU, it is indicated for the treatment of adult patients with ALK-positive advanced NSCLC not previously treated with an ALK inhibitor, or whose disease has progressed after using either alectinib or ceritinib, or crizotinib and at least one other ALK inhibitor.

Associated Conditions

  • Advanced Non-Small Cell Lung Cancer (NSCLC)
  • Metastatic Non-Small Cell Lung Cancer

FDA Approved Products

Lorbrena
Manufacturer:U.S. Pharmaceuticals
Route:ORAL
Strength:25 mg in 1 1
Approved: 2023/03/22
NDC:63539-927
Lorbrena
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:ORAL
Strength:25 mg in 1 1
Approved: 2023/04/10
NDC:0069-0227
Lorbrena
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:ORAL
Strength:100 mg in 1 1
Approved: 2023/04/10
NDC:0069-0231

Singapore Approved Products

LORVIQUA FILM-COATED TABLET 100MG
Manufacturer:Pfizer Manufacturing Deutschland GmbH
Form:TABLET, FILM COATED
Strength:100 MG
Online:Yes
Approved: 2019/10/16
Approval:SIN15831P
LORVIQUA FILM-COATED TABLET 25MG
Manufacturer:Pfizer Manufacturing Deutschland GmbH
Form:TABLET, FILM COATED
Strength:25mg
Online:Yes
Approved: 2019/10/16
Approval:SIN15830P

Drug Development Updates

Stay informed with timely notifications on clinical trials and research advancements.

© Copyright 2025. All Rights Reserved by MedPath