US- FDA Oncologic Drugs Advisory Committee (ODAC) Will Review AZ’s Imfinzi (durvalumab) for Neoadjuvant and Adjuvant Resectable NSCLC on Jul. 25, 2024

On July 25, 2024, the FDA Oncologic Drugs Advisory Committee (ODAC) will host a public meeting to (1) review a supplemental biologics license application (sBLA) for durvalumab, and (2) discuss whether sponsors should be required to adequately justify treatment both before and after surgery for resectable non-small cell lung cancer (NSCLC).

Summary:

Date/Time: July 25, 2024 @ 9:00AM – 2:15 PM ET

Location: Hybrid. Broadcast link will be made available 2 days prior to meeting.

The FDA ODAC will review the sBLA for durvalumab by AstraZeneca in combination with chemotherapy as neoadjuvant treatment, followed by monotherapy after surgery for adult patients with resectable NSCLC.

FDA will have a general discussion about whether sponsors should be required to adequately justify treatment of patients both neoadjuvant and adjuvant for resectable NSCLC prior to an approval that includes both therapies. 

Background:

Durvalumab was initially approved in 2017 and is a PD-L1 blocking antibody. It has been approved for multiple indications including unresectable NSCLC, metastatic NSCLC, extensive stage small cell lung cancer (SCLC), biliary tract cancer, and hepatocellular carcinoma.

This FDA ODAC is of interest to Gilead’s solid tumor product development and will provide learnings from other companies conducting studies for neoadjuvant and adjuvant indications in resectable NSCLC.

Sources:

Link to FDA ODAC Information Page (Meeting broadcast link will be posted here 2 days prior to meeting)

Link to US Federal Register announcement

Link to durvalumab label