Pfizer Receives FDA Approval for Sigvotatug Vedotin in CEACAM5-Positive Lung Cancer

Pfizer today announced that the FDA has approved sigvotatug vedotin for the treatment of adults with CEACAM5-positive non-small cell lung cancer who have received prior platinum-based chemotherapy and anti-PD-1/L1 therapy. In the Phase 3 FORTIS trial, sigvotatug vedotin demonstrated a statistically significant improvement in overall survival compared to docetaxel. Sigvotatug vedotin is an antibody-drug conjugate targeting CEACAM5. This approval provides patients with CEACAM5-positive NSCLC a new targeted treatment option.