Pfizer's Lorlatinib Scores European Approval In ALK-Positive Lung Cancer

The European Commission has approved Pfizer Inc's PFE Lorviqua (lorlatinib) for a form of advanced non-small-cell lung cancer (NSCLC).

• Lorlatinib is available in the U.S. under the brand name Lorbrena.
• The approval covers lorlatinib as monotherapy for anaplastic lymphoma kinase (ALK)- positive advanced NSCLC previously not treated with an ALK inhibitor. 
• Related: Pfizer's Lorbrena Wins Full FDA Approval As First-Line Treatment Of ALK-Positive Lung Cancer.
• The approval for the first-line use is based on the pivotal Phase 3 CROWN trial results, in which Lorviqua reduced the risk of disease progression or death by 72% compared to Xalkori (crizotinib). 
• As a secondary endpoint, the confirmed objective response rate (ORR) was 76% with Lorviqua and 58% with Xalkori. 
• Price Action: PFE shares are up 2.16% at $54.52 during the market session on the last check Friday.