On September 25, 2024, the U.S. Food and Drug Administration (FDA) approved Tagrisso (osimertinib) for people with unresectable stage 3 (III) non-small cell lung cancer (NSCLC). It’s approved for people who have both: 

  • Disease that has not progressed during or after chemoradiation therapy, and
  • Tumors that have EGFR exon 19 or exon 21 L858R mutations. 

This latest approval is based on the results of the LAURA study, which looked at people with stage 3 (III) NSCLC with specific mutations (EGFR exon 19 or exon 21 L858R) who had not progressed during or after chemoradiation. Participants were treated with either Tagrisso (osimertinib) or a placebo and were followed until either disease progression or the side effects from the treatment became too harmful for the participant to continue. The study found that people receiving Tagrisso (osimertinib) went much longer without disease progression compared to participants receiving the placebo. 

Tagrisso (osimertinib) has previously been approved for a number of indications in NSCLC. Please speak with your healthcare team for more information about Tagrisso (osimertinib) to 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.