Literature DB >> 30604291

Lorlatinib: First Global Approval.

Yahiya Y Syed1.   

Abstract

Lorlatinib is an oral small molecule inhibitor of anaplastic lymphoma kinase (ALK) and C-ros oncogene 1 (ROS1) kinase developed by Pfizer for the treatment of ALK-positive non-small cell lung cancer (NSCLC). Based on results from a phase I/II trial, lorlatinib received approval in Japan in September 2018 and in the USA in November 2018 for the treatment of ALK-positive NSCLC. This article summarizes the milestones in the development of lorlatinib leading to the first global approval for this indication.

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Year:  2019        PMID： 30604291     DOI： 10.1007/s40265-018-1041-0

Source DB:  PubMed          Journal:  Drugs        ISSN： 0012-6667            Impact factor:   9.546


  15 in total

Review 1.  Small molecules in targeted cancer therapy: advances, challenges, and future perspectives.

Authors:  Lei Zhong; Yueshan Li; Liang Xiong; Wenjing Wang; Ming Wu; Ting Yuan; Wei Yang; Chenyu Tian; Zhuang Miao; Tianqi Wang; Shengyong Yang
Journal:  Signal Transduct Target Ther       Date:  2021-05-31

2.  Lorlatinib Exposure-Response Analyses for Safety and Efficacy in a Phase I/II Trial to Support Benefit-Risk Assessment in Non-Small Cell Lung Cancer.

Authors:  Joseph Chen; Ana Ruiz-Garcia; Leonard P James; Gerson Peltz; Holger Thurm; Jill Clancy; Jennifer Hibma
Journal:  Clin Pharmacol Ther       Date:  2021-06-26       Impact factor: 6.903

3.  Symptomatic CNS Radiation Necrosis Requiring Neurosurgical Resection During Treatment with Lorlatinib in ALK-Rearranged NSCLC: A Report of Two Cases.

Authors:  Viola W Zhu; Misako Nagasaka; Takafumi Kubota; Kunil Raval; Natasha Robinette; Octavio Armas; Wajd Al-Holou; Sai-Hong Ignatius Ou
Journal:  Lung Cancer (Auckl)       Date:  2020-01-14

Review 4.  How to select the best upfront therapy for metastatic disease? Focus on ALK-rearranged non-small cell lung cancer (NSCLC).

Authors:  Bing Xia; Misako Nagasaka; Viola W Zhu; Sai-Hong Ignatius Ou; Ross A Soo
Journal:  Transl Lung Cancer Res       Date:  2020-12

5.  Population pharmacokinetic model with time-varying clearance for lorlatinib using pooled data from patients with non-small cell lung cancer and healthy participants.

Authors:  Joseph Chen; Brett Houk; Yazdi K Pithavala; Ana Ruiz-Garcia
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2021-02-01

6.  A new ALK inhibitor overcomes resistance to first- and second-generation inhibitors in NSCLC.

Authors:  Yue Lu; Zhenzhen Fan; Su-Jie Zhu; Xiaoxing Huang; Zhongji Zhuang; Yunzhan Li; Zhou Deng; Lei Gao; Xuehui Hong; Ting Zhang; Li Li; Xihuan Sun; Wei Huang; Jingfang Zhang; Yan Liu; Baoding Zhang; Jie Jiang; Fu Gui; Zheng Wang; Qiyuan Li; Siyang Song; Xin Huang; Qiao Wu; Lanfen Chen; Dawang Zhou; Jianming Zhang; Cai-Hong Yun; Liang Chen; Xianming Deng
Journal:  EMBO Mol Med       Date:  2021-11-30       Impact factor: 12.137

7.  Comparative efficacy and safety of first-line treatments for advanced non-small cell lung cancer with ALK-rearranged: a meta-analysis of clinical trials.

Authors:  Hao-Chuan Ma; Yi-Hong Liu; Kai-Lin Ding; Yu-Feng Liu; Wen-Jie Zhao; Yan-Juan Zhu; Xue-Song Chang; Ya-Dong Chen; Zhen-Zhen Xiao; Ya-Ya Yu; Rui Zhou; Hai-Bo Zhang
Journal:  BMC Cancer       Date:  2021-11-26       Impact factor: 4.430

Review 8.  Treatment Sequencing for Anaplastic Lymphoma Kinase-Rearranged Non-Small-Cell Lung Cancer.

Authors:  Diego Kauffmann-Guerrero; Kathrin Kahnert; Rudolf M Huber
Journal:  Drugs       Date:  2021-01       Impact factor: 9.546

9.  Phase 1 Study Evaluating the Effects of the Proton Pump Inhibitor Rabeprazole and Food on the Pharmacokinetics of Lorlatinib in Healthy Participants.

Authors:  Huiping Xu; Melissa T O'Gorman; Sunil Nepal; Lee P James; Katherine Ginman; Yazdi K Pithavala
Journal:  Clin Pharmacol Drug Dev       Date:  2021-07-20

10.  Pharmacokinetics of Lorlatinib After Single and Multiple Dosing in Patients with Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer: Results from a Global Phase I/II Study.

Authors:  Lee P James; Karen J Klamerus; Ganesh Mugundu; Joseph Chen; Melissa T O'Gorman; Yazdi K Pithavala
Journal:  Clin Pharmacokinet       Date:  2021-05-03       Impact factor: 6.447
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