FDA Expands LORBRENA Approval for First-Line ALK-Positive Lung Cancer Treatment
The U.S. Food and Drug Administration (FDA) has expanded the approval for Pfizer's LORBRENA® (lorlatinib) to include the first-line treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC).
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for LORBRENA® (lorlatinib). The drug is now approved for the first-line treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), including those with brain metastases. The FDA also converted the drug's 2018 accelerated approval to full approval.
The expanded approval is based on results from the Phase 3 CROWN trial. In the study, LORBRENA demonstrated a 72% reduction in the risk of disease progression or death compared to XALKORI® (crizotinib) in a previously untreated patient population. The trial also showed significant efficacy in treating brain metastases, a common complication in ALK-positive NSCLC.
LORBRENA is a third-generation ALK inhibitor designed to target common resistance mutations and penetrate the central nervous system. The CROWN study results were published in The New England Journal of Medicine, highlighting its effectiveness in patients with and without brain metastases.
This latest FDA approval allows LORBRENA to be used earlier in the treatment of ALK-positive NSCLC, potentially offering improved outcomes for a broader group of patients. The application was reviewed under the FDA's Real-Time Oncology Review (RTOR) pilot program.