CHMP opinion positive for Lorviqua as first-line treatment for ALK-positive advanced NSCLC.- Pfizer Inc.
The CHMP’s opinion will now be verified by the European Commission (EC) with a decision expected in the coming months. The application for the first-line use of Lorviqua was based on the results of the pivotal Phase III CROWN trial, in which Lorviqua reduced the risk of disease progression or death by 72% compared to Xalkori(crizotinib). In patients with measurable brain metastases, 82% of patients in the Lorviqua arm experienced an intracranial response (71% experiencing an intracranial complete response), compared to 23% of Xalkori patients.
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