Roche Receives FDA Approval for Alecensa as Adjuvant Treatment for ALK-Positive NSCLC

Roche today announced that the FDA has approved Alecensa (alectinib) as adjuvant treatment for adults with resected ALK-positive non-small cell lung cancer (NSCLC). In the Phase 3 ALINA trial, Alecensa demonstrated a statistically significant improvement in disease-free survival compared to platinum-based chemotherapy. The hazard ratio was 0.24, representing a 76% reduction in the risk of disease recurrence or death. At 2 years, 93.8% of patients receiving Alecensa were disease-free compared to 63.0% for chemotherapy. This approval provides patients with resected ALK-positive NSCLC a highly effective adjuvant treatment option.