EU Approves Pfizer’s Lorviqua for Treating ALK-Positive Advanced Lung Cancer

The European Commission has granted Pfizer’s Lorviqua (lorlatinib) — branded in the U.S. as Lorbrena — marketing authorization as a first-line treatment for adults with anaplastic lymphoma kinase (ALK)-positive advanced nonsmall-cell lung cancer (NSCLC).

The approval was supported by results from a 296-person phase 3 study, which demonstrated that Lorviqua reduced the risk of disease progression by 72 percent in newly diagnosed adults when compared with Pfizer’s Xalkori (crizotinib).

The commission’s decision followed a thumbs up from the European Medicines Agency’s Committee for Medicinal Products for Human Use in December.

Lorviqua was previously conditionally authorized in 2019 as a monotherapy for adults with ALK-positive advanced NSCLC whose disease progressed following treatment with alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at least one other ALK TKI therapy.