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Study Design1L study design2L+ study designEfficacy1L overall efficacy1L CNS efficacy1L 36-month overall efficacy1L 36-month CNS efficacy2L+ efficacySafetyPooled Safety: all lines1L safety2L+ safetyDosing & Therapy ManagementDosingTherapy management
Prescribing Information 

The information on this website is based on data from adult patients with ALK-positive advanced NSCLC (anaplastic lymphoma kinase positive advanced non small cell lung cancer) treated with LORVIQUA▼(lorlatinib), produced in line with the LORVIQUA (lorlatinib) Summary of Product Characteristics.
LORVIQUA (lorlatinib) Prescribing Information click here.
▼LORVIQUA is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. Adverse event reporting information can also be found at the bottom of the page.

LORVIQUA was designed to have improve Blood-Brain Barrier penetration to address the challenge of CNS Progression head on2,3LORVIQUA showed compelling CNS efficacy in patients with and without brain metastases, both in terms of response and duration.1,2,3  Intracranial Overall Response in Patients with measurable CNS lesions at baseline1
Intracranial ORR (N=30)a,b

aIntracranial response was assessed by an independent committee using modified RECIST, version 1.12
bPatients with measurable CNS metastases at baseline.2
Data cutoff: 20 March 2020.2

  • Median IC-DoR: Not estimable (95% Cl, NE-NE) with LORVIQUA vs 10 months (95% Cl, 9-11) with crizotinib1
CNS progression delayed in nearly all LORVIQUA-treated patients at 1 year2 Time to intracranial progression by BICR at 12 months (ITT population, N=296)1,2 Time to intracranial progression by BICR at 12 months (ITT population, N=296)1,2 ReferencesGraph adapted from  Shaw AT, Bauer TM, de Marinis F, et al; CROWN Trial Investigators. First-line lorlatinib or crizotinib in advanced ALK-positive lung cancer. N Engl J Med. 2020;383(21):2018-2029

BICR=blinded independent central review; CNS=central nervous system; HR=hazard ratio; IC-DoR=intracranial duration of response; IC-ORR=intracranial objective response rate; ITT=intention to treat.ReferencesReferences:1. Pfizer. LORVIQUA (lorlatinib) Summary of Product Characteristics.2. Shaw AT, Bauer TM, de Marinis F, et al; CROWN Trial Investigators. First-line lorlatinib or crizotinib in advanced ALK-positive lung cancer. N Engl J Med. 2020;383(21):2018-2029.
3. Solomon, Bauer at al; Efficacy and safety of first-line lorlatinib versus crizotinib in patients with advanced, ALK-positive non-small-cell lung cancer: updated analysis of data from the phase 3, randomised, open-label CROWN study. Lancet Respir Med 2023;11: 354–66Efficacy
LORVIQUA safety profile
 Review the safety Time to intracranial progression by BICR at 12 months (ITT population, N=296)1,2
PP-LOR-IRL-0069 February 2024 Legal Category S1A Further information available on request

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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