On August 15, 2024, the US Food and Drug Administration (FDA) approved a new treatment regimen for people newly diagnosed with early-stage, resectable (able to be removed by surgery) non-small cell lung cancer (NSCLC) whose tumors do not have known EGFR mutations or ALK rearrangements.
The recent approval offers another immunotherapy-based treatment regimen for people with stage IIA-IIIB NSCLC—the combination of durvalumab (Imfinzi®) with chemotherapy before surgery, followed by durvalumab after surgery.
People with early-stage, resectable NSCLC treated with chemotherapy and surgery still have high rates of recurrence. This FDA approval allows the addition of durvalumab, a type of immunotherapy, to patients’ treatment plans, which may provide longer survival benefits.
Both durvalumab and chemotherapy are given through IV infusions.
The FDA’s approval of this therapeutic regimen is based on the results of the AEGEAN phase III clinical trial, which demonstrated that combining durvalumab with chemotherapy and surgery gave a 32% decrease in the risk of recurrence or death (event-free survival) compared to using chemotherapy and surgery alone.
The trial enrolled 820 patients from 264 cancer centers in over 25 countries around the world.
Durvalumab is already approved by the FDA for the treatment of extensive-stage small cell lung cancer as well as other cancer types (such as liver cancer and endometrial cancer).
Learn more about this FDA approval.
If you have NSCLC, the LUNGevity NSCLC Patient Gateway has more information about available treatments, finding a specialist, clinical trials, online support groups, and more.