Wednesday, July 8, 2026

Drug profile · INN

lorlatinib

lorlatinib (LORVIQUA) is a eml4-alk inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved Antineoplastic and immunomodulating agents (L01) L01ED05
US status approved
Patents linked 0
Pipeline programs 6
News articles 0
Drug details — lorlatinib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
0
Programs
6
Data quality
0.84

Quick answer

lorlatinib (LORVIQUA) is a eml4-alk inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN lorlatinib
Brand LORVIQUA
Mechanism EML4-ALK inhibitor
Target ALK tyrosine kinase receptor
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation TABLET
ATC code L01ED05

Mechanism of action

EML4-ALK inhibitor

Primary target: ALK tyrosine kinase receptor

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved

Pipeline programs

  1. B9991046 Phase 3 · First Biotech (Australia) · Cancer
  2. LORLATINIB Phase 3 · First Biotech (Australia) · Advanced ALK positive non-small cell lung cancer
  3. ABP-2019 Phase 2 · George Institute for · locally advanced (stage III) and not suitable for curative t
  4. IFCT-2003 Phase 2 · CERo Therapeutics · Advanced ROS1-positive non-small cell lung cancer
  5. LORLATINIB Approved · First Biotech (Australia) · Lung cancer
  6. lorlatinib Approved · First People's Hospital · NSCLC

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is lorlatinib?

lorlatinib (LORVIQUA) is a eml4-alk inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for lorlatinib?

LORVIQUA is a marketed brand name for lorlatinib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of lorlatinib?

lorlatinib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.