Prescription medicine
Durvalumab Brand names: Imfinzi
Durvalumab (Imfinzi) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the durvalumab FDA label on DailyMed (effective August 31, 2026, AstraZeneca Pharmaceuticals LP); the BLA 761069 record on Drugs@FDA; every durvalumab label on DailyMed.
Highlights of the record
FDA label of August 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageIMFINZI 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) m
Forms and strengths
- 120 mg/2.4ml
- 500 mg/10ml
Injection (solution).
On the market
- Earliest approval on file
- May 1, 2017 Imfinzi, Astrazeneca Uk Ltd; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2019 0 Class I among all firms' recalls; latest June 12, 2019
- FAERS reports
- 20,225 through July 30, 2026
What is durvalumab used for?
From the label: indications and usageIMFINZI 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. ( 1.1 )
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. […]
Conditions named in the indications of durvalumab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Programmed Death Ligand-1 Blocker.
Source: FDA drug label (IMFINZI), AstraZeneca Pharmaceuticals LP, effective August 31, 2026 (SPL set 8baba4ea-2855-42fa-9bd9-5a7548d4cec3), via openFDA; the full label on DailyMed
Is there a generic for durvalumab (Imfinzi)?
No generic durvalumab is approved (Drugs@FDA, October 8, 2026).
- 2017 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has durvalumab been recalled?
The FDA's Enforcement Report lists 1 recall naming durvalumab since 2019: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the durvalumab label say about other medicines?
The durvalumab label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name durvalumab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carboplatin | warnings and precautions | IMFINZI with Carboplatin and Paclitaxel Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel. |
| Infliximab | warnings and precautions | Systemic corticosteroids were required in 64 patients (64/87) with pneumonitis who had received chemoradiation prior to initiation of IMFINZI, while 2 patients required use of infliximab with high-dose steroids. |
| Paclitaxel | warnings and precautions | IMFINZI with Carboplatin and Paclitaxel Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel. |
| Prednisone | warnings and precautions | In general, if IMFINZI requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. |
| Propylthiouracil | warnings and precautions | All patients required other therapy including hormone replacement therapy, thiamazole, carbimazole, propylthiouracil, perchlorate, calcium channel blocker, or beta-blocker. |
Source: FDA drug label (IMFINZI), AstraZeneca Pharmaceuticals LP, effective August 31, 2026 (SPL set 8baba4ea-2855-42fa-9bd9-5a7548d4cec3), via openFDA; the full label on DailyMed
What do FAERS reports show for durvalumab?
The FDA Adverse Event Reporting System holds 20,225 reports that list durvalumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,343 are coded as a death and 5,977 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as durvalumab?
16 other medicines are given the same way (intravenous) and in the same FDA class as durvalumab or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Pemetrexed | Lung cancer | 15 labelers | n/a | A presentation being discontinued |
| Etoposide | Lung cancer | 5 labelers | n/a | No current entry |
| Topotecan | Lung cancer | 4 labelers | n/a | No current entry |
| Nivolumab | Lung cancer | none listed | n/a | No current entry |
| Atezolizumab | Lung cancer | none listed | n/a | No current entry |
| Ipilimumab | Lung cancer | none listed | n/a | No current entry |
| Ramucirumab | Lung cancer | none listed | n/a | No current entry |
| Telisotuzumab vedotin | Lung cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as durvalumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to durvalumab
- 16 medicines for the same use
- Other programmed death ligand-1 blockers
- the pharmacologic class, with prices and generics
- Durvalumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other