Imfinzi

Treats resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC)…. BLA 761069, held by Astrazeneca Uk Ltd. Durvalumab.

As of Nov 14, 2026, BLA 761069 (Imfinzi), held by Astrazeneca Uk Ltd, was first approved by FDA on May 1, 2017, with 27 approved supplements and 0 published complete response letters.

First approved: May 1, 2017
Review: Priority
Supplements approved: 27
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated:

in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
as a single agent, for the treatment of adult patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below


May 28, 2026	Supplement 53Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Nov 25, 2025	Supplement 52Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 28, 2025	Supplement 50Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 28, 2025	Supplement 51Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 4, 2024	Supplement 49Efficacy (new indication or use) · Priority review	Approved	Label Letter
Aug 15, 2024	Supplement 43Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 14, 2024	Supplement 45Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 10, 2022	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 21, 2022	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Label Letter
Sep 2, 2022	Supplement 35Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 19, 2021	Supplement 29Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 18, 2020	Supplement 23Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 18, 2020	Supplement 24Efficacy (new indication or use) · Priority review	Approved	Label Letter
Mar 27, 2020	Supplement 18Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jul 19, 2019	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 16, 2018	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Letter Label
May 1, 2017	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Imfinzi50MG/ML · injectable;injection	Durvalumab	Rx

All 28 submissions, including labeling and manufacturing supplements


Aug 31, 2026	Supplement 60Labeling · Standard review	Approved	Letter Label
May 28, 2026	Supplement 53Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Nov 25, 2025	Supplement 52Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 28, 2025	Supplement 50Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 28, 2025	Supplement 51Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 4, 2024	Supplement 49Efficacy (new indication or use) · Priority review	Approved	Label Letter
Aug 15, 2024	Supplement 43Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 24, 2024	Supplement 47Labeling · Standard review	Approved	Label Letter
Jun 14, 2024	Supplement 45Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 22, 2024	Supplement 48Labeling · Standard review	Approved	Label Letter
Dec 20, 2023	Supplement 44Labeling · Standard review	Approved	Label Letter
Jun 16, 2023	Supplement 42Labeling · Standard review	Approved	Letter Label
Nov 10, 2022	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 21, 2022	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Label Letter
Sep 2, 2022	Supplement 35Efficacy (new indication or use) · Priority review	Approved	Letter Label
May 11, 2022	Supplement 32Labeling · Standard review	Approved	Label Letter
Jul 15, 2021	Supplement 28Labeling · Standard review	Approved	Letter Label
Feb 19, 2021	Supplement 29Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 18, 2020	Supplement 23Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 18, 2020	Supplement 24Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 18, 2020	Supplement 25Labeling · Standard review	Approved	Label Letter
Nov 10, 2020	Supplement 12Labeling · Standard review	Approved	Label Letter
Jun 5, 2020	Supplement 20Labeling · Standard review	Approved	Letter Label
Mar 27, 2020	Supplement 18Efficacy (new indication or use) · Priority review	Approved	Label Letter
Aug 26, 2019	Supplement 16Manufacturing	Approved	Label Letter
Jul 19, 2019	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 16, 2018	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Letter Label
May 1, 2017	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: BLA 761069
Drugs@FDA: Overview at FDA
Company: AstraZeneca UK Ltd

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters