> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Imfinzi OK’d for Resectable Lung Cancer
- URL: https://www.fdaweb.com/imfinzi-okd-for-resectable-lung-cancer/
- Published: 2024-08-16T12:00:00.000Z
- Updated: 2026-09-14T14:38:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157597

FDA has approved AstraZeneca’s Imfinzi (durvalumab) with platinum-containing chemotherapy as neoadjuvant treatment that is followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors greater than 4 cm or node positive) non-small cell lung cancer (NSCLC). The drug is intended for use in those with no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements, according to an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvantadjuvant-durvalumab-resectable-non-small-cell-lung-cancer?ref=fdaweb.com).

Approval was based on date from the company’s AEGEAN (NCT03800134) trial in 802 patients with previously untreated and resectable squamous or non-squamous NSCLC (Stage IIA to select Stage IIIB), the agency says. Patients were administered either durvalumab or placebo, with platinum-based chemotherapy, every three weeks for up to four cycles followed by either continued single-agent durvalumab or placebo for up to 12 cycles (adjuvant treatment), it says.

The trial’s efficacy outcome measures were event-free survival (EFS) and pathological complete response (pCR). FDA says median EFS was not reached, and the pCR rate was 17% and 4.3% in the durvalumab and placebo arms, respectively. “At the time of the prespecified interim analyses, overall survival (OS) was not formally tested for statistical significance; however, a descriptive analysis revealed no clear detriment,” it adds.