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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 Phase 1/2 study of LORVIQUA in patients with previously treated ALK-positive, 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=275)1
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Adverse reaction Any grade Grades 3 and 4
Hypercholesterolaemiaa 81.5% 15.6%
Hypertriglyceridaemiaa 60.4% 15.6%
Oedemaa 43.3% 2.2%
Peripheral neuropathya 29.8% 1.8%
Weight increased 18.2% 1.8%
Cognitive effectsa 17.8% 1.1%
Mood effectsa 14.9% 0.7%
Fatiguea 13.1% 0.4%
Diarrhoea 10.5% 0.4%
Arthralgia 10.2% 0.0%
AST increased 10.2% 0.4%

Adapted from Solomon NJ, et al. Lancet Oncol. 2018.

  • In patients receiving LORVIQUA, permanent discontinuations and dose reductions associated with adverse reactions occurred in 3.0% and 22.0% of patients, respectively1
  • Of the 295 patients on LORVIQUA, only 8.0% required dose modification due to CNS adverse reactions and 62.5% of these patients experienced resolution of CNS adverse reactions after dose modification2 
  • Adverse reactions can be effectively managed with dose modifications and/or standard supportive medical therapy2

Learn more about therapy management AST=aspartate aminotransferase; AR=adverse reaction.aCluster term comprising adverse events that represent similar clinical symptoms or syndromes.ReferencesSolomon 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;19:1654-1667.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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PP-LOR-IRL-0075 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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