Research & Development
The European Commission grants conditional marketing authorisation for Pfizer's LORVIQUA
10 May 2019 -

The European Commission has granted conditional marketing authorisation for Pfizer's LORVIQUA as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at least one other ALK TKI, it was reported yesterday.

The product is a third-generation ALK TKI that was specifically developed to penetrate the blood brain barrier, in the presence or absence of resistance mutations.

The conditional marketing authorisation was based on results from a non-randomised, dose-ranging and activity-estimating, multi-cohort, multi-centre Phase 1/2 study, B7461001, assessing the product for the treatment of patients with ALK-positive advanced NSCLC, who were previously treated with one or more ALK TKIs. A total of 139 patients with ALK-positive metastatic NSCLC after treatment with at least one second-generation ALK TKI, such as alectinib, brigatinib or ceritinib, were enrolled in the Phase two portion of the study.