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    Home > Active Ingredient News > Antitumor Therapy > Pfizer's third-generation ALK inhibitor lorlatinib (i.e. lorlatinib) is approved for marketing in China

    Pfizer's third-generation ALK inhibitor lorlatinib (i.e. lorlatinib) is approved for marketing in China

    • Last Update: 2022-05-19
    • Source: Internet
    • Author: User
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    In the past 50 years, many countries have reported that the incidence and mortality of lung cancer have increased significantly.


    In the past 50 years, many countries have reported that the incidence and mortality of lung cancer have increased significantly.


     

    Lorlatinib is an oral macrocyclic adenosine triphosphate competitive small molecule inhibitor of ROS1 and ALK receptor tyrosine kinases


    Lorlatinib has been approved for marketing in the United States and Japan in 2018, and in Europe in 2019


    For the first-line treatment of adults with ALK-positive metastatic non-small cell lung cancer; in the EU, lorlatinib is approved as a single agent for alectinib or ceritinib as the first ALK-TKI therapy, or for crizotinib Adult patients with ALK-positive advanced non-small cell lung cancer whose disease has progressed after treatment with tinib and at least one other ALK-TKI


    Main research and development progress of lorlatinib Main research and development progress of lorlatinib

    Main efficacy data of lorlatinib

    lorlatinib key efficacy data lorlatinib key efficacy data

    In the United States, lorlatinib was approved for the first-line treatment of NSCLC based on data from the CROWN study


    95% CI: 0.


    The clinical study is also the world's first pivotal study of lorlatinib on this target, which was just announced in China on March 22, 2022


    In addition to ALK mutations, ROS1 rearrangement, as an important lung cancer-related driver gene, is more common in young, non-smoking or light smoking patients with lung adenocarcinoma


    Lorlatinib is a novel, reversible, and potent small-molecule ALK and ROS1 inhibitor developed by Pfizer.


    Based on the dazzling research data, after being granted breakthrough therapy designation by the FDA in 2017, lorlatinib was approved in the United States and Japan in 2018, bringing solutions to patients with ALK resistance


    Lorlatinib's global launch history Lorlatinib's global launch history

    April 2017

    April 2017

    Lorlatinib was granted Breakthrough Therapy Designation by the FDA (U.


    Lorlatinib was granted Breakthrough Therapy Designation by the FDA (U.


    September 2018

    Japan approved lorlatinib for the treatment of ALK-positive advanced NSCLC who are intolerant to ALK inhibitors or progress after treatment


    Japan approved lorlatinib for the treatment of ALK-positive advanced NSCLC who are intolerant to ALK inhibitors or progress after treatment


    November 2018

    The FDA approved lorlatinib for patients with advanced NSCLC after progression on criazole or at least one ALK-TKI; or after progression on alectinib/ceritinib as first-line therapy


    The FDA approved lorlatinib for patients with advanced NSCLC after progression on criazole or at least one ALK-TKI; or after progression on alectinib/ceritinib as first-line therapy
    .

    March 2019

    March 2019

    The European Medicines Agency (EMA) approved the marketing of lorlatinib, and the indication is also the second-line treatment of ALK
    .

    The European Medicines Agency (EMA) approved the marketing of lorlatinib, and the indication is also the second-line treatment of ALK
    .

    February 2020

    Lorlatinib was officially listed commercially in Hong Kong
    .

    April 2022

    Lorlatinib officially launched in mainland China

    Lorlatinib related reports

    lorlatinib related reports lorlatinib related reports

    J Thorac Oncol: Lorlatinib is still effective after progression in patients with ALK+ NSCLC

    J Thorac Oncol: Lorlatinib is still effective after progression in patients with ALK+ NSCLC

    J Thorac Oncol: Efficacy of lorlatinib in Chinese patients with previously treated ALK-positive advanced or metastatic NSCLC

    J Thorac Oncol: Efficacy of lorlatinib in Chinese patients with previously treated ALK-positive advanced or metastatic NSCLC

    Nature: CLIP1-LTK, a new target for non-small cell lung cancer, was discovered, and lorlatinib works well

    Nature: CLIP1-LTK, a new target for non-small cell lung cancer, was discovered, and lorlatinib works well

    sNDA for LORBRENA (lorlatinib) in previously untreated ALK-positive lung cancer has been granted priority review by the U.
    S.
    FDA

    sNDA for LORBRENA (lorlatinib) in previously untreated ALK-positive lung cancer has been granted priority review by the U.
    S.
    FDA

    Oncologist: Real-world data show no significant difference between third-line ALK inhibitor and chemotherapy in patients with metastatic ALK-rearranged non-small cell lung cancer (NSCLC)

    Oncologist: Real-world data show no significant difference between third-line ALK inhibitor and chemotherapy in patients with metastatic ALK-rearranged non-small cell lung cancer (NSCLC)

    NEJM: Lung cancer-targeted drug successfully rescues children with ALK fusion-positive high-grade glioma on the brink of death

    NEJM: Lung cancer-targeted drug successfully rescues children with ALK fusion-positive high-grade glioma on the brink of death

    Front Oncol: Bayesian network meta-analysis comparing efficacy and safety of first-line treatment regimens in patients with ALK-positive NSCLC

    Front Oncol: Bayesian network meta-analysis comparing efficacy and safety of first-line treatment regimens in patients with ALK-positive NSCLC

    Ann Oncol: Extracranial and intracranial efficacy of lorlatinib in second-generation TKI-treated ALK-positive NSCLC patients

    Ann Oncol: Extracranial and intracranial efficacy of lorlatinib in second-generation TKI-treated ALK-positive NSCLC patients

    Better than crizotinib, FDA approves lorlatinib for first-line treatment of ALK-positive non-small cell lung cancer (NSCLC) patients

    Better than crizotinib, FDA approves lorlatinib for first-line treatment of ALK-positive non-small cell lung cancer (NSCLC) patients

    NEJM: "Head-to-Head" Phase III Study Confirms Lorlatinib Significantly Superior to Crizotinib in ALK-Positive Non-Small Cell Lung Cancer

    NEJM: "Head-to-Head" Phase III Study Confirms Lorlatinib Significantly Superior to Crizotinib in ALK-Positive Non-Small Cell Lung Cancer

    Lorlatinib, a new-generation targeted drug for lung cancer: significantly improves progression-free survival in patients with ALK-positive NSCLC

    Lorlatinib, a new-generation targeted drug for lung cancer: significantly improves progression-free survival in patients with ALK-positive NSCLC

    Lancet Oncol: lorlatinib in ROS1-positive advanced NSCLC

    Lancet Oncol: lorlatinib in ROS1-positive advanced NSCLC

    JCO: Does the EML4-ALK variant subtype influence efficacy and outcomes in ALK-positive patients?

    JCO: Does the EML4-ALK variant subtype influence efficacy and outcomes in ALK-positive patients?

    Lancet Oncol: Lorlatinib in ALK or ROS1 Rearranged Non-Small Cell Lung Cancer

    Lancet Oncol: Lorlatinib in ALK or ROS1 Rearranged Non-Small Cell Lung Cancer

     

     



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