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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.

Generally manageable safety profile with largely mild-to-moderate adverse reactions1

Data described here are reflective of the CROWN trial, a Phase 3 study of LORVIQUA vs crizotinib in patients with previously untreated, ALK-positive, locally advanced or metastatic NSCLC.1 

The most common adverse reactions are reported below.

ARs (any grade) occurring in ≥10% of patients treated with LORVIQUA (N=149)1,a
Scroll left to view table
Adverse reaction Any grade Grades 3 and 4
Hypercholesterolaemiab 70.5% 16.1%
Hypertriglyceridaemiab 63.8% 20.1%
Oedemab 55.0% 4.0%
Weight increased 38.3% 16.8%
Peripheral neuropathyb 33.6% 2.0%
Cognitive effectsb,c 21.5% 2.0%
Diarrhoea 21.5% 1.3%
Anemia 19.5% 2.7%
Fatigueb 19.5% 1.3%
Hypertension 18.1% 10.1%
Vision disorderb 18.1% 0.0%
Increased ALT level 17.4% 2.7%
Constipation 17.4% 0.0%
Mood effectsb,d 16.1% 1.3%
Nausea 14.8% 0.7%
Increased AST level 14.1% 2.0%
Vomiting 12.8% 0.7%
Hyperlipidemia 10.7% 2.0%
Adapted from Shaw AT, et al. N Engl J Med. 2020.
  • In the CROWN study, permanent discontinuations and dose reductions associated with adverse reactions occurred in 7.0% and 21.0% of patients with LORVIQUA and 9.0% and 15.0% with crizotinib, respectively1,a 
  • 35.0% of patients receiving LORVIQUA in the CROWN study reported CNS adverse events, but by time of analysis 56.0% had resolved and most required no intervention (33.0% resolved without intervention, 17.0% with dose modification)2,a 
  • Adverse reactions can be effectively managed with dose modifications and/or standard supportive medical therapy, without affecting the efficacy of LORVIQUA2,3 

Learn more about therapy management

ALT=alanine aminotransferase; AST=aspartate aminotransferase; AR=adverse reaction.aBased on data from 18-month median follow-up of 149 patients who received LORVIQUA 100 mg once daily in the Phase 3 CROWN trial.1bThis category comprised a cluster of adverse events that may represent similar clinical symptoms or syndromes. cCognitive effects with a frequency of at least 1% included memory impairment, disturbance in attention, confusion, amnesia, cognitive disorder, and delirium.dMood effects with a frequency of at least 1% included anxiety, depression, affect lability, affective disorder, agitation, irritability, and altered mood.References: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.Solomon BJ, Bauer TM, Ou SHI, et al. Post hoc analysis of lorlatinib efficacy and safety in patients with ALK-positive advanced non-small-cell lung cancer from the Phase III CROWN study. J Clin Oncol. Published online May 23, 2022. doi: 10.1200/JCO.21.02278.Bauer TM, Felip E, Solomon BJ, et al. Clinical management of adverse events associated with lorlatinib. Oncologist. 2019;24(8):1103-1110.Safety
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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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