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AboutStudy 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

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 is a 3rd-generation ALK TKI designed to address unmet medical needs1-4
  • LORVIQUA is a novel, third-generation ALK TKI that has been designed to address two major unmet needs in the treatment of advanced or metastatic ALK+ NSCLC1-3
    • CNS metastases
    • ALK resistance mutations
  • It is the first ALK TKI designed with a macrocyclic ring structure, which provides the ability to effectively cross the blood-brain barrier where it is retained at therapeutic levels2-6
  • LORVIQUA has shown in vitro and clinical activity against ALK resistance mutations, such as the hard-to-treat G1202R mutation, the most common secondary ALK mutation identified in patients prescribed second-generation ALK inhibitors1,6-8

The macrocyclic ring structure of LORVIQUA2

ALK=anaplastic lymphoma kinase; CNS=central nervous system; NSCLC=non-small cell lung cancer; TKl=tyrosine kinase inhibitor.ReferencesReferences:Shaw AT, Solomon BJ, Besse B, et al. ALK resistance mutations and efficacy of lorlatinib in advanced anaplastic lymphoma kinase-positive non-small-cell lung cancer. J Clin Oncol. 2019;37(16):1370-1379.Johnson TW, Richardson PF, Bailey S, et al. Discovery of (10R)-7- amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2H-8,4-(metheno)pyrazolo[4,3-h][2,5,11]-benzoxadiazacyclotetradecine-3-carbonitrile (PF-06463922), a macrocyclic inhibitor of anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) with preclinical brain exposure and broad-spectrum potency against ALK-resistant mutations. J Med Chem. 2014;57(11):4720-4744. 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(12):1654-1667. Bauer TM, Shaw AT, Johnson ML, et al. Brain penetration of lorlatinib: cumulative incidences of CNS and non-CNS progression with lorlatinib in patients with previously treated ALK-positive non-small-cell lung cancer. Target Oncol. 2020;15(1):55-65.Shaw AT, Felip E, Bauer TM, et al. Lorlatinib in non-small-cell lung cancer with ALK or ROS1 rearrangement: an international, multicentre, open-label, single-arm first-in-man phase 1 trial. Lancet Oncol. 2017;18:1590-1599.Hochmair MJ, Fabikan H, Illini O, et al. Later-line treatment with lorlatinib in ALK- and ROS1-rearrangement-positive NSCLC: a retrospective, multicenter analysis. Pharmaceuticals. 2020;13(11):371.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.Gainor JF, Dardaei L, Yoda S, et al. Molecular mechanisms of resistance to first- and second­-generation ALK inhibitors in ALK-rearranged lung cancer. Cancer Discov. 2016;6(10):1118-1133. 
LORVIQUA efficacy
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PP-LOR-IRL-0065 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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