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ALK positive lung cancer is a primary malignant lung tumor whose cells contain a characteristic abnormal configuration of DNA wherein, most frequently, the echinoderm microtubule-associated protein-like 4 gene is fused to the anaplastic lymphoma kinase (ALK) gene.
The drug treats a type of non-small cell lung cancer with a genetic mutation called ALK. Non-small cell lung cancers account for about 85% of lung cancer diagnoses, and ALK-positive cancers ...
Xalkori , produced by Pfizer, was approved by the FDA for treatment of late stage lung cancer on August 26, 2011. [76] Early results of an initial Phase I trial with 82 patients with ALK induced lung cancer showed an overall response rate of 57%, a disease control rate at 8 weeks of 87% and progression free survival at 6 months of 72%.
Efficacy was evaluated in eXALT3 (NCT02767804), an open-label, randomized, active-controlled, multicenter trial in 290 participants with locally advanced or metastatic ALK-positive non-small cell lung cancer who had not previously received an ALK-targeted therapy. [2] Participants were randomized 1:1 to receive ensartinib or crizotinib. [2]
The European Commission has approved Pfizer Inc's (NYSE: PFE) Lorviqua (lorlatinib) for a form of advanced non-small-cell lung cancer (NSCLC). Lorlatinib is available in the U.S. under the brand ...
Approval required a companion molecular test for the EML4-ALK fusion. In March 2016, the FDA approved crizotinib in ROS1-positive non-small cell lung cancer. [19] In October 2012, the European Medicines Agency (EMA) approved the use of crizotinib to treat non-small cell lung cancers that express the abnormal anaplastic lymphoma kinase (ALK ...
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