The approval is based on positive results from the phase 3 ALINA study that demonstrated Alecensa reduced the risk of disease recurrence or death by 76% compared with platinum-based chemotherapy in people with completely resected IB to IIIA ALK-positive NSCLC.
According to Roche, about half of people living with early-stage NSCLC experience disease recurrence following surgery despite adjuvant chemotherapy; Alecensa can now address this unmet need.