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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 dataIn 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 2017Lorlatinib 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 2019The 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 reportsJ 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+ NSCLCJ 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 NSCLCNature: 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 wellsNDA for LORBRENA (lorlatinib) in previously untreated ALK-positive lung cancer has been granted priority review by the U.
S.
FDA
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 deathFront 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 NSCLCAnn 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 patientsBetter 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) patientsNEJM: "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 CancerLorlatinib, 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 NSCLCLancet Oncol: lorlatinib in ROS1-positive advanced NSCLC
Lancet Oncol: lorlatinib in ROS1-positive advanced NSCLCJCO: 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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