7 May 2019 - Pfizer today announced that the European Commission granted conditional marketing authorisation for Lorviqua (lorlatinib, available in the U.S., Canada and Japan under the brand name Lorbrena), as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase positive advanced non-small cell lung cancer whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor therapy, or crizotinib and at least one other ALK tyrosine kinase inhibitor. 

Lorviqua is a third-generation ALK tyrosine kinase inhibitor 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, evaluating Lorviqua for the treatment of patients with ALK-positive advanced NSCLC, who were previously treated with one or more ALK TKIs.

Read Pfizer press release