Durvalumab

Durvalumab (Imfinzi) is an immunotherapy cancer treatment used for non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), bile duct and gallbladder cancer, hepatocellular carcinoma, endometrial cancer, bladder cancer, and gastric and gastroesophageal junction cancers in certain patients.

Durvalumab is an immune checkpoint inhibitor that targets the PD-L1 protein on cancer cells, helping the immune system more effectively recognize and attack cancer cells. This may help increase overall survival, lower the risk of cancer spreading, and help shrink tumors, depending on the type of cancer.

Durvalumab is given as an infusion into a vein every 2, 3, or 4 weeks, depending on your condition. Other medicines may be part of your treatment plan, depending on your cancer type.

The Imfinzi brand of durvalumab first received FDA approval on May 1, 2017, for AstraZeneca, initially for the treatment of advanced bladder cancer. Since then, its approved uses have expanded to include multiple additional cancer types. Its latest approval was granted on 25 November 2025 for gastric and gastroesophageal junction (GEJ) cancers in certain patients.

Durvalumab works by blocking the PD-L1 protein on cancer cells, allowing your immune system to recognize and attack them. This helps slow the spread of cancer and can improve survival.

Durvalumab’s class of medicines is called checkpoint inhibitors.

Durvalumab’s mechanism of action (MOA) is as a programmed death-ligand 1 (PD-L1) blocking antibody. It binds and blocks PD-L1, so there is no interaction with PD-1 and CD80. This means that the immune response is now activated to work against the cancer cells.

It can be used for cancers that have a protein called PD-L1 on the outside of the cancer cell. The PD-L1 protein helps the cancer cells hide from the immune system so that cancer cells can survive and multiply. When Imfinzi blocks PD-L1, it means the immune system is able to find cancers and destroy them.

Durvalumab is used for non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer, hepatocellular carcinoma, endometrial cancer, and muscle-invasive bladder cancer (MIBC) and gastric and gastroesophageal junction (GEJ) cancers in specific patients.

Durvalumab FDA-approved indications are:

Small Cell Lung Cancer (NSCLC)

Resectable NSCLC

• Indication: For adult patients with resectable NSCLC (tumors ≥ 4 cm and/or node-positive) without EGFR mutations or ALK rearrangements.
• Use: In combination with platinum-containing chemotherapy as neoadjuvant treatment before surgery. Followed by Imfinzi as a single agent as adjuvant treatment after surgery.

Unresectable Stage III NSCLC

• Indication: For adult patients with unresectable Stage III NSCLC whose disease has not progressed after concurrent platinum-based chemotherapy and radiation therapy.
• Use: Imfinzi as a single agent.

Metastatic NSCLC

• Indication: For adult patients with metastatic NSCLC and no sensitizing EGFR mutations or ALK tumor aberrations.
• Use:

Small Cell Lung Cancer (SCLC)

Limited-Stage SCLC (LS-SCLC)

• Indication: For adult patients with limited-stage SCLC whose disease has not progressed after concurrent platinum-based chemotherapy and radiation.
• Use:

Extensive-Stage SCLC (ES-SCLC)

• Indication: For adult patients with extensive-stage SCLC.
• Use:

Biliary Tract Cancer (BTC)

• Indication: For adult patients with locally advanced or metastatic BTC.
• Use:

Unresectable Hepatocellular Carcinoma (uHCC)

• Indication: For adult patients with unresectable hepatocellular carcinoma.
• Use:

Endometrial Cancer

• Indication: For adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), confirmed by an FDA-approved test.
• Use: Imfinzi in combination with carboplatin and paclitaxel, Followed by Imfinzi as a single agent.

High-Risk Non-Muscle-Invasive Bladder Cancer

• Indication: For adult patients with high-risk non-muscle-invasive bladder cancer (NMIBC)
• Use:

Muscle-Invasive Bladder Cancer (MIBC)

• Indication: For adult patients with muscle-invasive bladder cancer undergoing radical cystectomy.
• Use: Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment Followed by Imfinzi as a single agent as adjuvant treatment after surgery.

Gastric & Gastroesophageal Junction (GEJ) Cancers

Resectable, Early-Stage & Locally Advanced Gastric/GEJ Cancer (Stages II, III, IVA)

• Indication: For adult patients with resectable, early-stage, or locally advanced (Stages II, III, IVA) gastric or gastroesophageal junction cancers.
• Use:

Durvalumab is given as an infusion into a vein, usually once every 2, 3 or 4 weeks. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take about 1 hour to complete.

Durvalumab may also cause your immune system to attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, pituitary, or adrenal glands.

Call your doctor at once if you have new or unusual symptoms, such as: tiredness, mood changes, headaches, vision problems, muscle weakness, stomach problems, weight changes, skin rash, hair loss, bleeding or bruising, yellowing of your skin or eyes, increased or decreased urination, dark urine, bloody or tarry stools, worsening cough, chest pain, or trouble breathing.

Infusion-Related Reactions. Your infusion may be slowed, interrupted or permanently discontinued if you have an infusion-related reaction, depending on the severity of the reaction.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT). Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.

Embryo-Fetal Toxicity: This medicine can cause fetal harm. Females of reproductive potential should be advised of the potential risk to a fetus and should use effective contraception.

You should not use this infusion if you are allergic durvalumab or any of the inactive ingredients.

To make sure this medicine is safe for you, tell your doctor if you have an active infection or if you have ever had:

• an organ transplant or a stem cell transplant (recent or planned);
• lung disease or breathing problems;
• liver disease;
• radiation treatment of your chest area; or
• an autoimmune disorder such as lupus, ulcerative colitis, or Crohn's disease.

Pregnancy

Durvalumab may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose. Tell your doctor if you become pregnant.

Breastfeeding

Do not breastfeed while using medicine, and for at least 3 months after your last dose.

Common durvalumab side effects

Common durvalumab side effects include cough, rash, shortness of breath (dyspnea), tiredness (fatigue), cold symptoms (respiratory tract infections), inflammation of the lungs (pneumonitis), when used as a single agent for Stage III NSCLC.

When used with other cancer treatments, common durvalumab side effects may include nausea, constipation, decreased appetite, feeling weak or tired, bone or muscle pain, cough, feeling short of breath, muscle or bone pain, cold symptoms such as stuffy nose, sneezing, sore throat, abdominal pain, fever, itchy skin, rash, painful urination, hair loss, vomiting, nerve inflammation (causing symptoms such as numbness, weakness, tingling, or burning), changes blood tests including decreased magnesium, increased ALT, and increased AST. Side effects profiles are dependent on the specific combination of therapies.

The most common side effects of durvalumab when used with BCG in adults with high-risk NMIBC include increased liver function tests, muscle or bone pain, urinary tract infection, decreased lymphocyte counts, increased level of potassium in the blood, urinating more often, pain or discomfort with urination, decreased level of sodium in the blood, decreased red blood cells (anemia), feeling tired, blood in the urine, rash, increased level of creatinine in the blood, and fever.

Immune-mediated hypothyroidism was reported in 14% of people receiving Imfinzi in combination with carboplatin and paclitaxel. Events resolved in some patients, but all required endocrine therapy.

Serious durvalumab side effects

Durvalumab may cause serious side effects including severe allergic reactions. Get emergency medical help if you have signs of an allergic reaction to this medicine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the durvalumab injection. Tell your caregiver right away if you feel light-headed or itchy or if you have a fever, chills, neck or back pain, trouble breathing, or flushing (warmth, redness, or tingly feeling).

This medicine causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.

Call your doctor at once if you have:

• chest pain, new or worsening cough, feeling short of breath;
• severe stomach pain, diarrhea, bloody or tarry stools;
• new or worsening skin rash, itching, or blistering;
• fever, flu-like symptoms;
• pain or burning when you urinate;
• problems in other organs - mood or behavior changes, neck stiffness, confusion, eye pain or redness, vision problems;
• liver problems - loss of appetite, upper stomach pain, drowsiness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes);
• kidney problems - little or no urination, red or pink urine, swelling in your feet or ankles;
• transplant rejection - rash with blisters and peeling, watery diarrhea, stomach pain, vomiting, loss of appetite, fever, bruising or bleeding, jaundice, pain or swelling near your transplanted organ; or
• signs of a hormonal disorder - unusual headaches, feeling light-headed or very tired, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, vomiting, hair loss, feeling cold, weight gain, or weight loss.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Small Cell Lung Cancer:

30 kg or less:20 mg/kg IV in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 4 weeks as a single agent until disease progression, unacceptable toxicityNOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information.Greater than 30 kg:1500 mg IV in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 1500 mg every 4 weeks as a single agent until disease progression or unacceptable toxicityNOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information.Use: First-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with etoposide and either carboplatin or cisplatin.

Usual Adult Durvalumab Dose for Biliary Tract Cancer:

30 kg or less:20 mg/kg IV in combination with chemotherapy every 3 weeks (21 days) for up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent until disease progression or until unacceptable toxicityNOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for gemcitabine and cisplatin for dosing information.

Greater than 30 kg:1500 mg IV in combination with chemotherapy every 3 weeks (21 days) for up to 8 cycles, followed by 1500 mg every 4 weeks as a single agent until disease progression or until unacceptable toxicityNOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for gemcitabine and cisplatin for dosing information.

Use: Locally advanced or metastatic biliary tract cancer (BTC) in combination with gemcitabine and cisplatin.

Usual Adult Dose for Unresectable Hepatocellular Carcinoma:

Less than 30 kg:20 mg/kg in combination with tremelimumab-actl 4 mg/kg as a single dose at Cycle 1/Day 1, followed by durvalumab as a single agent every 4 weeks.

Greater than or equal to 30 kg:1,500 mg in combination with tremelimumab-actl 300 mg as a single dose at Cycle 1/Day 1, followed by durvalumab as a single agent every 4 weeks.Use: The treatment of adult patients with unresectable hepatocellular carcinoma in combination with tremelimumab-actl.

Usual Adult Dose for dMMR endometrial cancer

30 kg or less:15 mg/kg in combination with carboplatin and paclitaxel* every 3 weeks (21 days) for 6 cycles, followed by durvalumab 20 mg/kg every 4 weeks as a single agent until disease progression or unacceptable toxicity.

Greater than 30 kg:

1,120 mg in combination with carboplatin and paclitaxel* every 3 weeks (21 days) for 6 cycles, followed by durvalumab 1,500 mg every 4 weeks as a single agent.

Use: to treat endometrial cancer that has spread (advanced) or come back (recurrent) and tests show the tumor is mismatch repair deficient (dMMR), durvalumab is used with carboplatin plus paclitaxel followed by single-agent durvalumab.

Usual Adult Dose for Other Cancers:

For detailed dose information for non-Small Cell Lung Cancer, high-risk non-muscle invasive bladder cancer (NMIBC), and muscle invasive bladder cancer (MIBC), see Detailed Imfinzi Dosage.

Durvalumab is available as

Imfinzi brand

• 500 mg/10 mL (50 mg/mL) solution in a single-dose vial.
• 120 mg/2.4 mL (50 mg/mL) solution in a single-dose vial.

Durvalumab J-code is J9173, Injection durvalumab (Imfinzi), 10 mg.

J codes are used for medicines that are not taken orally and include injections, inhalations chemotherapies. J codes are important, accurate, and consistent coding for billing and reimbursement purposes. They are part of the Healthcare Common Procedure Coding System (HCPCS). Your physician will need an Imfinzi J-code when filling out forms for your treatment.

Imfinizi brand vials size and NDC codes

• 500 mg/10 ml 50 units NDC 0310-4611-50
• 120 mg/24 ml 12 units NDC 0310-4500-12

Call your doctor for instructions if you miss an appointment for your injection.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with durvalumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Review the Durvalumab Package Insert (Imfinzi Package Insert) for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Durvalumab Package Insert is sometimes called Durvalumab Prescribing Information (PI) or Durvalumab FDA label.

Active ingredient: durvalumab

Imfinzi Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, polysorbate 80, Water for Injection, USP.

Durvalumab manufacturer is AstraZeneca UK Limited, 1 Francis Crick Ave. Cambridge, England CB2 0AA - Imfinzi brand

Durvalumab is manufactured for AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 - Imfinzi brand.