![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » Pfizer Earns European OK for Lorviqua
Pfizer Earns European OK for Lorviqua
May 21, 2019
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.
Upcoming Events
-
21Oct