The European Commission has approved Pfizer Inc's (NYSE: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.
