Conditional EU approval for Lorviqua in NSCLC

Following a positive opinion in March from the European Medicines Agency advisory committee, the European Commission (EC) has granted conditional marketing authorization for US pharma giant Pfizer’s (NYSE: PFE) Lorviqua (lorlatinib).

The approval is 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.

Conditional approval means that the product was approved based on less data because of the significant medical need, but post-marketing studies will be required for full approval.