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LORVIQUA®▼ (lorlatinib) Prescribing Information for United Kingdom click here. XALKORI® (crizotinib) Prescribing Information for United Kingdom click here.
Adverse event reporting information can be found at the bottom of the page.

In the United Kingdom, LORVIQUA® (lorlatinib) is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-posi­tive advanced non-small cell lung cancer (aNSCLC), previously not treated with an ALK inhibitor or whose disease has progressed after prior treat­ment with an ALK inhibitor.1

LORVIQUA 1L TREATMENT CAN OFFER ALK +ve aNSCLC PATIENTS >5 YEARS OF PFS1*†

A strong start against ALK +ve aNSCLC with 1L LORVIQUA

CROWN is an ongoing, international, randomised, open-label phase 3 trial investigating the efficacy and safety of first-line lorlatinib and crizotinib in patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC)2

DOWNLOAD A SHORT 2-PAGE SUMMARY OF THE 5 YEAR CROWN TRIAL HERELoading After 5 years of follow-up, median PFS with lorlatinib treatment has not been reached (95% CI: 64.3-NR)

vs 9.1 months (95% CI: 7.4-10.9) for crizotinib1

LIMITATIONS: The results of this unplanned, investigator-assessed analysis are descriptive. No formal hypothesis testing was performed given that the PFS endpoint was previously met in the CROWN trial primary analysis; results are presented descriptively.1The primary endpoint of PFS was met in the CROWN trial BICR-assessed primary analysis (median follow-up for PFS: 18.3 months for patients receiving LORVIQUA and 14.8 months for patients receiving crizotinib); median PFS was not estimable for the LORVIQUA arm. An unplanned INV- assessed follow-up analysis was performed at a median follow-up for PFS of approximately 60 months for patients on LORVIQUA (55 months for patients on crizotinib) to confirm the effect of LORVIQUA relative to crizotinib with longer follow-up. All tumour-related endpoints reported in the 5 year analysis are investigator assessed 1,2 Patient and Safety Outcomes for 1L LORVIQUA at 5 Years 
the list below is not exhaustive, always refer to SmPC for full list of Adverse event (SmPC)  
  • 5% of patients discontinued LORVIQUA (8 of 149) due treatment-related adverse reactions, which occurred in the first 26 months.1
  • The most common grade 3 and 4 adverse events in the lorlatinib-treated group were hypertriglyceridaemia (25%), increased weight (23%), hypercholesterolaemia (21%), and hypertension (12%).1
  • Grade 3 to 4 Adverse Reactions occured in 77% of patients receiving LORVIQUA (n=149). Majority of adverse events were effectively managed with dose interruptions/dose reductions.1
  • CNS adverse reaction such as mood, cognition,speech and psychosis occurred in 42% of patients treated with LORVIQUA (n=149). Only 3 patients who experienced treatment-related CNS adverse reactions (two had confusional state and one had nightmares) permanently discontinued lorlatinib.1
National and International Guidance for 1L ALK +ve aNSCLC
  • LORVIQUA is a first-line treatment option recommended by ESMO for the treatement of ALK +ve advanced NSCLC.3
  • LORVIQUA is a Category 1 and an option recommended by the NCCN Guidelines for first-line treatement of ALK +ve advanced or metastatic NSCLC.4
  • LORVIQUA is accepted for use within NHSScotland as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.5
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1L=first-line; ALK=anaplastic lymphoma kinase; ALK+=anaplastic lymphoma kinase-positive; aNSCLC=advanced non-small cell lung cancer; BICR=blinded independent central review; CI=confidence interval; CNS=central nervous system; ESMO=European Society for Medical Oncology; HR=hazard ratio; INV=investigator; PFS=progression-free survival.▼This medicinal product is subject to additional monitoring.6ReferencesReferences:Solomon BJ,et al. Lorlatinib versus crizotinib in patients with advanced ALK-positive non-small cell lung cancer: 5-year outcomes from the phase III CROWN study. J Clin Oncol. 2024. doi:10.1200/JCO.24.00581.Shaw AT, 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.Hendriks LE, et al. Oncogene addicted metastatic non-small-cell lung cancer; ESMO Clinical Practice Guideline for diagnosis, treatment, and follow-up. Ann Oncol. 2023;34(4):339-357.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.5.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed April 24, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for thier application or use in any way.

Scottish Medicines Consortium Product Update SMC2415. Published 4 February 2022Pfizer. LORVIQUA (lorlatinib) Summary of Product Characteristics for United Kingdom.
PP-LOR-GBR-0737. May 2025

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