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OverviewStarting Strong in 1LAbout LORVIQUA®Study Design1L study design2L+ study designEfficacy1L overall efficacy1L CNS efficacy1L 5-Year overall efficacy1L 5-Year CNS efficacy2L+ efficacySafetyPooled Safety: all lines1L safety2L+ safetyDosing & Therapy ManagementOnce-daily dosingARs of clinical interestTherapy managementResourcesMaterialsVideos
Prescribing Information 
Generally manageable safety profile with largely mild-to-moderate adverse reactions1-4

Data described here are reflective of the 547 adult patients treated with LORVIQUA® in the Phase 1/2 trial of previously treated patients, the Phase 3 CROWN trial of previously untreated patients and in Study B, a single-arm, multicentre Phase 4 study of previously treated patients1

ARs (any grade) occurring in ≥20% of patients treated with LORVIQUA® (N=547)1
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Adverse reaction                                   All grades            Grades 3 and 4      
Hypercholesterolaemiaa79%19.2%
Hypertriglyceridaemiab67.5%20.3%
Oedemac55.4%2.9%
Peripheral neuropathyd44.2%2.6%
Weight increased29.8%11%
Cognitive effectse27.4%3.5%
Fatiguef30.7%1.1%
Arthralgia27.8%0.7%
Diarrhoea22.7%1.8%
Mood effectsg21.4%1.3%

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    ReferencesaHypercholesterolaemia (including blood cholesterol increased, hypercholesterolaemia).1bHypertriglyceridaemia (including blood triglycerides increased, hypertriglyceridaemia).1cOedema (including generalised oedema, oedema, oedema peripheral, peripheral swelling, swelling).1dPeripheral neuropathy (including burning sensation, dysaesthesia, formication, gait disturbance, hypoaesthesia, motor dysfunction, muscular weakness, neuralgia, neuropathy peripheral, neurotoxicity, paraesthesia, peripheral motor neuropathy, peripheral sensory neuropathy, peroneal nerve palsy, sensory disturbance).1eCognitive effects (including events from SOC nervous system disorders: amnesia, cognitive disorder, dementia, disturbance in attention, memory impairment, mental impairment; and also including events from SOC psychiatric disorders: attention deficit/hyperactivity disorder, confusional state, delirium, disorientation, reading disorder). Within these effects, terms from SOC nervous system disorders were more frequently reported than terms from SOC psychiatric disorder.1fFatigue (including asthenia, fatigue).1gMood effects (including affective disorder, affect lability, aggression, agitation, anger, anxiety, bipolar I disorder, depressed mood, depression, depressive symptom, euphoric mood, irritability, mania, mood altered, mood swings, panic attack, personality change, stress).1
    1L=first-line; 2L=second-line; AR=adverse reaction; SOC=system organ class.

    Refer to the Lorviqua® Summary of Product Characteristics for the most up to date safety profile'    ReferencesReferences:Pfizer. LORVIQUA® (lorlatinib) Summary of Product CharacteristicsSolomon BJ, Liu G, Felip E, 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 42,3400-3409(2024)Solomon BJ, Besse B, Bauer TM, et al. Lorlatinib in patients with ALK-positive non-small-cell lung cancer: results from a global phase 2 study. Lancet Oncol. 2018.;19:1654-67Shaw 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.    Safety
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    PP-LOR-IRL-0179 | AUG2025

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