FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Pfizer Earns European OK for Lorviqua

May 22, 2019
A A

Pfizer gained the European Commission’s conditional marketing authorization for Lorviqua (lorlatinib) as a monotherapy for anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer.

Lorviqua, a third-generation ALK tyrosine kinase inhibitor (TKI) therapy specifically developed to penetrate the blood brain barrier, is approved for adult patients whose diseases have progressed after alectinib or ceritinib as their first ALK TKI therapy, or crizotinib and at least one other ALK-TKI.

The drug is the pharma giant’s second lung cancer drug approved in Europe within two months. Vizimpro was first.

View today's stories