On Dec. 18, 2024, the U.S. Food and Drug Administration (FDA) approved Ensacove (ensartinib) for people with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have an ALK mutation and have not previously received an ALK-targeted therapy. 

Ensacove (ensartinib) represents a new first-line treatment option for those with ALK-positive NSCLC, found in about 4% of lung cancer diagnoses. 

This approval is based on the results of the eXALT3 study, which looked at treating people with locally advanced or metastatic ALK-positive NSCLC who had not previously been given an ALK-targeted therapy. Participants received either Ensacove (ensartinib) or Xalkori (crizotinib) as first-line treatment for ALK-positive NSCLC. Results showed that participants given Ensacove (ensartinib) experienced a significant improvement in the amount of time before progression. There was no meaningful difference in overall survival between the 2 groups. 

Please speak with your healthcare team for more information about Ensacove (ensartinib) and see if it may be a good option for you. If you have questions about treatment, trials, or biomarker testing, contact our LungMATCH team at support@go2.org or 1-800-298-2436.  

Read the full FDA announcement.