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Lorbrena

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Unmet Need Molecular Structure Guidelines Study design Efficacy Safety Dosing and Therapy Management Summary Important Safety Information Abbreviated Prescribing Information
Summary
  • LORBRENA™ demonstrated a significant improvement in PFS and superior intracranial response rates over crizotinib1*
  • LORBRENA™ is a treatment option for patients with ALK-positive advanced non-small-cell lung cancer who are treatment naïve or have been previously treated with at least one ALK tyrosine kinase inhibitor, including second-generation drugs, and who might have brain metastases2
  • LORBRENA™ showed 72% reduction in risk of progression or death vs. crizotinib5

*Study B7461006 (CROWN) - A total of 296 patients were randomized to LORBRENA™ (n=149) or crizotinib (n=147)1
†B7461006 - The safety of LORBRENA™ was evaluated in 149 patients1

Abbreviations: ALK, Anaplastic lymphoma kinase; CNS, Central nervous system; CROWN, A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC: NSCLC, Non-small cell lung cancer; PFS, Progression-free survival; TKI, Tyrosine kinase inhibitor.

References:Lorbrena™ EDA leaflet approval date 26/4/2021.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. 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. 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.Shaw AT, Bauer TM, de Marinis F, et al; CROWN Trial Investigators. N Engl J Med. 2020;383(21):2018-2029

MOH Approval No: HF0098OA54/062022
Invalidation date: 12/06/2024

Adverse events should be reported. Adverse events can be reported to [email protected]

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