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FDA Approval: Durvalumab (Imfinzi) for Lung Cancer
FDA approved Durvalumab (Imfinzi), an anti-PD-L1 checkpoint inhibitor, for certain people with lung cancer. What was approved, the evidence, and what it does and doesn't mean.
Original commentary from the Cancer Explained editorial team.
Please note: this page is educational only — it is not medical advice, and it does not speculate about anyone’s health beyond reliable public reporting. For questions about your own health, talk with your healthcare team.
The treatment that comes after the treatment
Durvalumab, sold as Imfinzi, is a programmed death-ligand 1 blocking antibody, usually written PD-L1. Its FDA label carries an Initial U.S. Approval date of 2017.
Its best-known role in lung cancer is unusual. It is given to people whose disease has not grown after chemotherapy and radiation given together. Nothing is being shrunk at that point. The drug is there to hold the ground that chemoradiation gained.
Doctors call this consolidation. It answers one problem. Many people with stage III lung cancer finish chemoradiation well and then relapse anyway.
How PD-L1 blockade works
T cells carry a receptor called PD-1. Many tumors display a protein called PD-L1 that binds it. When those two lock together, the T cell stands down. It is a real off switch, borrowed by the cancer.
Durvalumab binds PD-L1 so the lock cannot close, and the T cell keeps working. Our page on immunotherapy covers this family of drugs.
What the label covers now
The lung indications alone are several.
- With platinum chemotherapy before surgery, then alone after it, for non-small cell lung cancer that can be removed. Tumors must be 4 centimeters or larger, or involve nodes, with no known EGFR or ALK change.
- Alone, for unresectable stage III NSCLC whose disease has not progressed after concurrent platinum chemotherapy and radiation.
- With tremelimumab and platinum chemotherapy, for metastatic NSCLC with no sensitizing EGFR mutation or ALK change.
- Alone, for limited-stage small cell lung cancer whose disease has not progressed after concurrent platinum chemotherapy and radiation.
- With etoposide and either carboplatin or cisplatin, as first treatment for extensive-stage small cell lung cancer.
The trial behind the small cell lung cancer use
On December 4, 2024, the FDA approved durvalumab for adults with limited-stage small cell lung cancer whose disease had not progressed after concurrent platinum chemotherapy and radiation.
The evidence was ADRIATIC, a randomized, double-blind, placebo-controlled trial in 730 patients. There were three arms: durvalumab alone, durvalumab with tremelimumab, or placebo. The comparison that mattered was durvalumab alone against placebo.
Overall survival improved significantly, with a hazard ratio of 0.73. Median overall survival was 55.9 months with durvalumab and 33.4 months with placebo.
Progression-free survival also improved significantly, with a hazard ratio of 0.76. Median progression-free survival was 16.6 months and 9.2 months.
This is worth pausing on. Overall survival counts deaths, not scan findings. A trial that shows it has answered the harder question. Many cancer drug approvals do not.
The most common reactions, at 20 percent or more, were pneumonitis or radiation pneumonitis, and fatigue. Durvalumab is given as an infusion every 4 weeks, with the amount set by the treating team according to body weight. It runs until the disease grows, side effects become unacceptable, or 24 months pass.
The risks that come with releasing the immune system
The label's leading warning is immune-mediated adverse reactions, which may be severe or fatal and can occur in any organ or tissue.
It names pneumonitis, colitis, hepatitis, and damage to hormone glands. It also names skin reactions, kidney inflammation, rejection of a transplanted organ, and pancreatitis.
Monitoring is specified. Liver enzymes, creatinine, and thyroid function are checked at the start and from time to time during treatment. The drug is held or stopped based on the type and severity of the reaction.
Pneumonitis deserves particular attention in this setting, because these patients have just had radiation to the chest. New or worsening cough, breathlessness, or chest tightness after chemoradiation should be reported the same day rather than attributed to the radiation and waited out.
The label also warns about infusion reactions and about fetal harm. It warns too about serious problems in people who have a donor stem cell transplant before or after a PD-1 or PD-L1 blocking antibody.
When to get checked
NCI's symptom list for small cell lung cancer is the same practical list that applies across lung cancer. Check with a doctor for:
- Chest discomfort or pain.
- A cough that does not go away or gets worse over time.
- Trouble breathing, or wheezing.
- Blood in sputum, the mucus coughed up from the lungs.
- Hoarseness, or trouble swallowing.
- Loss of appetite, or weight loss for no known reason.
- Feeling very tired.
- Swelling in the face and in the veins of the neck.
That last one is not vague. Swelling of the face and neck veins can mean a tumor is pressing on the large vein returning blood to the heart, and it needs urgent assessment.
For screening, a yearly low-dose CT scan is recommended for adults aged 50 through 80 with a 20 pack-year smoking history who smoke now or quit within the past 15 years.
How these stages are defined
Small cell lung cancer is staged differently from other lung cancers, because it tends to spread early. NCI uses two categories.
Limited-stage means the cancer is in the lung where it started, and may have spread to the area between the lungs or to lymph nodes above the collarbone.
Extensive-stage means it has spread beyond those areas to other parts of the body.
Non-small cell lung cancer uses the numbered stages. Stage III sits in the middle. The disease has spread within the chest but not to distant organs, and often cannot be removed by surgery.
Diagnosis for both begins with imaging and lab tests, and is confirmed by biopsy.
The wider numbers
These SEER figures cover all lung and bronchus cancer across the US population, both small cell and non-small cell. They describe a group, not a person.
Five-year relative survival is 29.5 percent for cases from 2016 to 2022. By stage it is 65.5 percent while confined to the lung, 38.2 percent at nearby lymph nodes, and 10.5 percent once it has spread further. About 24 percent are found at that first stage, while 51 percent are already distant. An estimated 229,410 new cases and 124,990 deaths are projected for 2026.
Lung cancer causes 20.0 percent of all cancer deaths in the United States, more than any other type. Our page on lung cancer covers the differences between the types.
What to keep in perspective
A survival benefit measured across 730 people is a real result about a group. It does not predict what happens to one person. The medians quoted are middles of wide ranges.
Consolidation also assumes a person finished chemoradiation and is well enough to go on. Not everyone is. Whether durvalumab fits depends on stage, response to the earlier treatment, lung function, autoimmune history, and the goals of care.
Sources
- DailyMed, IMFINZI (durvalumab) label, Initial U.S. Approval 2017 — https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8baba4ea-2855-42fa-9bd9-5a7548d4cec3
- FDA, FDA approves durvalumab for limited-stage small cell lung cancer — https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-limited-stage-small-cell-lung-cancer
- NCI, Durvalumab — https://www.cancer.gov/about-cancer/treatment/drugs/durvalumab
- NCI PDQ, Small Cell Lung Cancer Treatment (Patient Version) — https://www.cancer.gov/types/lung/patient/small-cell-lung-treatment-pdq
- NCI PDQ, Non-Small Cell Lung Cancer Treatment (Patient Version) — https://www.cancer.gov/types/lung/patient/non-small-cell-lung-treatment-pdq
- SEER Cancer Stat Facts, Lung and Bronchus Cancer — https://seer.cancer.gov/statfacts/html/lungb.html
- USPSTF, Lung Cancer: Screening — https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening
How this article was prepared
An AI-assisted editorial system helped prepare this page. No named medical reviewer has reviewed it unless one is listed.
The National Cancer Information Foundation publishes Cancer Explained. This page is for learning. It is not medical advice and does not suggest a test or treatment.
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Put the story in context
Prevention, possible warning signs, screening, and diagnosis
This story relates to Lung cancer. The information below is general: it does not reveal anything else about a public person’s health, and not every point applies to every cancer. Personal advice depends on age, symptoms, family history, exposures, and medical history.
Prevention and risk reduction
Not every cancer can be prevented. Avoiding tobacco, protecting skin from ultraviolet radiation, limiting alcohol, staying active, and receiving recommended HPV or hepatitis B vaccination can lower the risk of certain cancers. A risk factor is not a prediction or a cause in one individual.
Symptoms and possible early signs
Possible signs vary and are often caused by conditions other than cancer. Changes worth discussing include a new lump, unexplained bleeding or weight loss, a persistent cough, lasting bowel or bladder changes, a changing skin spot, or symptoms that persist or worsen. Some early cancers cause no symptoms.
Screening and early detection
Screening looks for certain cancers before symptoms begin. Recommended tests exist only for some cancers and depend on age and risk. Screening can have benefits and harms; it is not the same as evaluating a new symptom, and there is no single routine scan or blood test that reliably screens for every cancer.
How cancer is diagnosed
Diagnosis may involve a history and exam, imaging, laboratory tests, and often a biopsy. Pathology can identify the cancer type and may test biomarkers that guide treatment. Symptoms, screening results, tumor markers, or online stories alone cannot confirm cancer.
Learn about this story’s cancer topic
A public story may encourage questions, but it should not be used to estimate your risk or choose testing. Contact a healthcare professional about a persistent or concerning change. Seek urgent care for severe or rapidly worsening symptoms.