On August 15, 2024, the U.S. Food and Drug Administration (FDA) granted approval for the immunotherapy drug Imfinzi (durvalumab) to be used in combination with chemotherapy (neoadjuvant, treatment given before surgery) as well as on its own after surgery (adjuvant). This treatment is for people who have been diagnosed with non-small cell lung cancer (NSCLC) that is considered:

  • Resectable (able to be operated on)
  • Early stage (stages 2A-3B [IIA-IIIB])
  • Does not have mutations in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)

The FDA previously approved Imfinzi (durvalumab) for other uses, including in for people with lung cancer. However, this newest approval is based on data from their AGEAN trial, published in October 2023. This trial found that people who received the Imfinzi (durvalumab) + neoadjuvant chemotherapy regimen before surgery, along with Imfinzi (durvalumab) monotherapy (treatment with a single drug or therapy) after surgery, showed a 32% reduction in the likelihood of disease recurrence, progression, or death when compared to the group who received chemotherapy alone.

As we see an increase in early detection and screening methods, more and more people are being diagnosed with lung cancer at earlier stages, which makes surgery a more viable option for them. Currently, U.S. estimates are that 25-30% of people will have an early-stage diagnosis of NSCLC. Now, in addition to being treated with surgery and chemotherapy, there is a new immunotherapy approval, which can provide another treatment option for people in this situation.

If you think this approval may be relevant to your treatment, talk to your healthcare team. 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.