Pfizer’s lung cancer drug Lorviqua recommended for marketing authorization in EU

Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for LORVIQUA (lorlatinib, approved in the U.S., Canada, and Japan under the brand name LORBRENA), an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI). The CHMP has adopted a positive opinion recommending conditional marketing authorization for LORVIQUA as monotherapy for the treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib or ceritinib as the first ALK TKI therapy, or crizotinib and at least one other ALK TKI. Conversion to normal approval will be contingent on provisions of comprehensive data confirming that the benefit-risk balance is positive. The CHMP’s opinion will now be reviewed by the European Commission (EC), with a decision expected in the coming months.

“Addressing drug resistance and relapse remains a challenge in the treatment of ALK-positive non-small cell lung cancer,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “This CHMP opinion represents a step forward in bringing LORVIQUA to patients in Europe living with advanced ALK-positive non-small cell lung cancer who have limited treatment options.”

The Marketing Authorization Application (MAA) for LORVIQUA was based on results from a non-randomized, dose-ranging and activity-estimating, multi-cohort, multi-center 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. A total of 229 patients with ALK-positive metastatic NSCLC were enrolled across various subgroups based on prior treatment.