Author: Matthew Reiss, MSE, PhD, Manager, Precision Medicine & Navigation, GO2 for Lung Cancer 

On April 18, 2024, the U.S. Food and Drug Administration (FDA) approved Alecensa (alectinib) following surgical resection for people living with early-stage ALK-positive non-small cell lung cancer (NSCLC). 

The approval is based on results from the ALINA study (NCT03456076). Participants with stage 1B (IB) to 3A (IIIA), ALK-positive NSCLC received 600 mg of Alecensa (alectinib) twice daily after surgery to remove the cancer. People treated with Alecensa (alectinib) had a meaningful reduction in disease recurrence or death compared to people treated with platinum-based chemotherapy following surgical resection. Additionally, participants receiving Alecensa (alectinib) experienced a lower rate of treatment-related adverse events requiring a change in therapy than participants treated with chemotherapy. 

ALK-positive lung cancer is found in about 4% of NSCLCs and is more common in younger populations (under age 55) and people with no history of smoking. Alecensa (alectinib) is the first therapy targeting ALK-positive NSCLC to receive early-stage approval for use following surgical resection. 

Read the full FDA announcement here.