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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
Molecular Structure

LORBRENA™: a 3rd-generation ALK TKI, designed to address the unmet medical needs2–4

  • LORBRENA™ is a ALK TKI with a macrocyclic ring designed to address the unmet needs in ALK+ advanced NSCLC2-4
     
  • LORBRENA™ is a kinase inhibitor with in vitro activity against ALK and ROS1. Demonstrated in vitro activity against multiple mutant forms of the ALK enzyme, including some mutations detected in tumors at the time of disease progression on crizotinib and other ALK inhibitors1
     
  • LORBRENA ™ has shown in vitro and clinical activity against ALK resistance mutations, such as the hard-to-treat G1202R mutation5,6

 

The macrocyclic ring structure of LORBRENA™2

 

 Abbreviations: ALK, Anaplastic lymphoma kinase; CNS, Central nervous system; NSCLC, Non-small cell lung cancer; TKI, Tyrosine kinase inhibitor

References:Lorbrena™ EDA leaflet approval date 26/4/2021.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.Johnson TW. Structural data in the discovery of lorlatinib and insights into mechanisms of ALK acquired resistance. Oral presentation at American Association for Cancer Research (AACR); 14–18 April 2018; Chicago, IL, USA. 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. 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, 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.

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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