Drug profile · INN
durvalumab
IMFINZI
durvalumab (IMFINZI) is a programmed cell death 1 ligand 1 inhibitor. Associated with AstraZeneca. Route of administration: injection. Current US regulatory status: approved.
Drug details — durvalumab
- US status
- approved
- Class
- Antineoplastic and immunomodulating agents (L01)
- Route
- INJECTION
- Patents
- 20
- Programs
- 127
- Data quality
- 0.84
Quick answer
durvalumab (IMFINZI) is a programmed cell death 1 ligand 1 inhibitor. Associated with AstraZeneca. Route of administration: injection. Current US regulatory status: approved.
Key facts
Mechanism of action
Programmed cell death 1 ligand 1 inhibitor
Primary target: Programmed cell death 1 ligand 1
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
| EMA | approved | — |
| TGA | approved | — |
| PMDA | approved | — |
Recent coverage
5 Notable Oncology FDA Approvals Granted in May: A B2B Analysis
In May 2026, the FDA granted five major oncology approvals, including a first-in-class combination for non-muscle invasive bladder cancer. This analysis covers the approvals, their competitive impact, and next milestones for pharma teams.
May 2026 FDA Oncology Actions: 8 Approvals Reshape the Landscape
In May 2026, the FDA issued 8 oncology and hematology approvals, including durvalumab for high-risk non-muscle invasive bladder cancer. This analysis covers the approvals, their competitive impact, and what to watch next in FDA oncology guidance.
Pharma bets on PD-1/VEGF bispecifics: Is lung cancer the wrong target?
While many drugmakers are focused on lung cancer for PD-1/VEGF bispecifics, emerging evidence shows the liver may offer higher value. This analysis covers the mechanism, key players, and strategic implications for pharma teams.
FDA Approves AstraZeneca's Imfinzi-BCG Combination for High-Risk NMIBC
The FDA has approved AstraZeneca's Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). This marks the first immunotherapy-based combination therapy approved for this indication.
Pipeline programs
Related & competitor drugs
Related patents
-
US 12357705
Negatively charged peg-lipid conjugates
granted -
US 12350383
Cationic lipids containing silicon
granted -
US 12083118
Substituted 1,1′-biphenyl compounds, analogues thereof, and methods using same
granted -
US 12042541
Lipids and compositions for the delivery of therapeutics
granted -
US 12023383
Lipid compositions
granted -
US 11712476
Lipids and compositions for the delivery of therapeutics
granted -
US 11702427
Substituted 2-pyridone tricyclic compounds, analogues thereof, and methods using same
granted -
US 11566002
Substituted tetrahydrocyclopenta[C]pyrroles, substituted dihydropyrrolizines, analogues thereof, and methods using same
granted -
US 11505551
Methods for preparing substituted pyridinone-containing tricyclic compounds
granted -
US 11395854
Trialkyl cationic lipids and methods of use thereof
granted -
US 11191849
Compositions and methods for delivering messenger RNA
granted -
US 11130740
Substituted 2,3-dihydro-1H-indene analogs and methods using same
granted -
US 11098010
Substituted dihydroindene-4-carboxamides and analogs thereof, and methods using same
granted -
US 11077197
Lipids and compositions for the delivery of therapeutics
granted -
US 11013726
Substituted pyridinone-containing trycyclic compounds, and methods using same
granted -
US 11001564
Substituted chromane-8-carboxamide compounds and analogues thereof, and methods using same
granted -
US 10953095
Lipid compositions
granted -
US 10835612
Lipids and compositions for the delivery of therapeutics
granted -
US 10821103
Substituted pyridinone-containing trycyclic compounds, and methods using same
granted -
US 10821186
Lipids and compositions for the delivery of therapeutics
granted
Frequently asked questions
What is durvalumab?
durvalumab (IMFINZI) is a programmed cell death 1 ligand 1 inhibitor. Associated with AstraZeneca. Route of administration: injection. Current US regulatory status: approved.
What is the brand name for durvalumab?
IMFINZI is a marketed brand name for durvalumab. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of durvalumab?
durvalumab has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.