Pfizer Receives Full FDA Approval for Lorbrena as First-Line ALK-Positive Lung Cancer Treatment

Pfizer today announced that the FDA has converted the accelerated approval of Lorbrena (lorlatinib) to full approval for the first-line treatment of adults with ALK-positive metastatic non-small cell lung cancer. The conversion was based on overall survival data from the Phase 3 CROWN trial demonstrating a statistically significant improvement in OS. At 5 years, lorlatinib demonstrated a 60% progression-free survival rate versus 8% for crizotinib. This full approval reinforces lorlatinib as the preferred first-line treatment for ALK-positive NSCLC.