AstraZeneca Imfinzi (durvalumab) Monograph

Published: November 07, 2025

Imfinzi (durvalumab) is AstraZeneca's FDA-approved immunotherapy for non-small cell lung cancer (NSCLC), small cell lung cancers (SCLC), locally advanced or metastatic biliary tract cancer (BTC), unresectable hepatocellular carcinoma (uHCC), cis-eligible muscle-invasive bladder cancer (MIBC), and primary advanced or recurrent dMMR endometrial cancer.

With multiple indications, Imfinzi's latest FDA approval came in March of 2025 for muscle invasive bladder cancer. That approval followed the three from the year before for small cell lung cancers and endometrial cancer. The following monograph details Imfinzi's multiple indications, along with a few examples from clinical guidelines.

Medication Overview:

Brand Name: Imfinzi
Generic Name: Durvalumab
Treatment for: NSCLC, LS-SCLC, ES-SCLC, BTC, uHCC, endometrial cancer, MIBC
Manufacturer: AstraZeneca
Initial FDA Approval: 2017

Imfinzi (durvalumab) Indications

Indicated Condition	Indication	Age	Year Approved
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.	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.	Adults	2024
Unresectable, Stage III NSCLC with no disease progression following concurrent platinum-based chemotherapy and radiation therapy.	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.	Adults	2018
Metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.	In combination with tremelimumab-actl and platinum-based chemotherapy, for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.	Adults	2022
Limited-stage small cell lung cancer (LS-SCLC) with no disease progression following concurrent platinum-based chemotherapy and radiation therapy.	As a single agent, for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.	Adults	2024
Extensive-stage small cell lung cancer (ES-SCLC).	In combination with etoposide and either carboplatin or cisplatin, as first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).	Adults	2020
Locally advanced or metastatic biliary tract cancer (BTC).	In combination with gemcitabine and cisplatin, as treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).	Adults	2022
Unresectable hepatocellular carcinoma (uHCC).	In combination with tremelimumab-actl, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).	Adults	2022
Primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-approved test.	In combination with carboplatin and paclitaxel followed by Imfinzi as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-approved test.	Adults	2024
Muscle invasie bladder cancer (MIBC).	In combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent Imfinzi as adjuvant treatment following radical cystectomy, for the treatment of adult patients with muscle invasive bladder cancer (MIBC).	Adults	2025

Warnings and Precautions

Immune-Mediated Adverse Reactions:

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, solid organ transplant rejection, and immune-mediated pancreatitis.

Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
Withhold or permanently discontinue based on severity and type of reaction.

Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue IMFINZI based on the severity of the reaction.

Complications of Allogeneic 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: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception.

Dosage and Administration

Administer Imfinzi as an intravenous infusion over 60 minutes after dilution.

Neoadjuvant and Adjuvant Treatment of Resectable NSCLC:

Weight ≥ 30 kg:
- Neoadjuvant: Imfinzi 1,500 mg in combination with chemotherapy every three weeks for up to four cycles prior to surgery.
- Adjuvant: Imfinzi 1,500 mg as a single agent every four weeks for up to 12 cycles after surgery.
Weight < 30 kg:
- Neoadjuvant: Imfinzi 20 mg/kg every 3 weeks in combination with chemotherapy for up to four cycles prior to surgery.
- Adjuvant: 20 mg/kg every four weeks as a single agent for up to 12 cycles after surgery.

Unresectable Stage III NSCLC, following concurrent platinum-based chemotherapy and radiation therapy:

Weight ≥ 30 kg: Imfinzi 10 mg/kg every 2 weeks or 1,500 mg every four weeks.
Weight < 30 kg: Imfinzi 10 mg/kg every two weeks.

Metastatic NSCLC:

Weight ≥ 30 kg: Imfinzi 1,500 mg every three weeks in combination with tremelimumab-actl 75 mg and platinum-based chemotherapy for four cycles, and then administer Imfinzi 1,500 mg every four weeks as a single agent with histology-based pemetrexed maintenance therapy every four weeks, and a fifth dose of tremelimumab-actl 75 mg in combination with Imfinzi dose six at week 16.
Weight < 30 kg: Imfinzi 20 mg/kg every three weeks in combination with tremelimumab-actl 1 mg/kg and platinum-based chemotherapy, and then administer Imfinzi 20 mg/kg every four weeks as a single agent with histology-based pemetrexed therapy every four weeks, and a fifth dose of tremelimumab-actl 1 mg/kg in combination with Imfinzi dose six at week 16.

LS-SCLC, following concurrent platinum-based chemotherapy and radiation therapy:

Weight ≥ 30 kg: 1,500 mg every four weeks.
Weight < 30 kg: 20 mg/kg every four weeks.

ES-SCLC:

Weight ≥ 30 kg: With etoposide and either carboplatin or cisplatin, administer Imfinzi 1,500 mg every three weeks in combination with chemotherapy, and then 1,500 mg every four weeks as a single agent.
Weight < 30 kg: With etoposide and either carboplatin or cisplatin, administer Imfinzi 20 mg/kg every three weeks in combination with chemotherapy, and then 10 mg/kg every two weeks as a single agent.

BTC:

Weight ≥ 30 kg: administer Imfinzi 1,500 mg every three weeks in combination with chemotherapy, and then 1,500 mg every four weeks as a single agent.
Weight < 30 kg: administer Imfinzi 20 mg/kg every three weeks in combination with chemotherapy, and then 20 mg/kg every four weeks as a single agent.

uHCC:

Weight ≥ 30 kg: Imfinzi 1,500 mg in combination with tremelimumab-actl 300 mg as a single
dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every four weeks.
Weight < 30 kg: Imfinzi 20 mg/kg in combination with tremelimumab-actl 4 mg/kg as a single
dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every four weeks.

dMMR endometrial cancer:

Weight ≥ 30 kg: Imfinzi 1,120 mg in combination with carboplatin and paclitaxel every three weeks for six cycles, followed by Imfinzi 1,500 mg every four weeks as a single agent.
Weight < 30 kg: Imfinzi 15 mg/kg in combination with carboplatin and paclitaxel every three weeks for six cycles, followed by Imfinzi 20 mg/kg every four weeks as a single agent.

MIBC:

Weight ≥ 30 kg:
- Neoadjuvant: Imfinzi 1,500 mg in combination with gemcitabine and cisplatin every three weeks for four cycles prior to surgery.
- Adjuvant: Imfinzi 1,500 mg every four weeks as a single agent for up to eight cycles after surgery.
Weight < 30 kg:
- Neoadjuvant: Imfinzi 20 mg/kg in combination with gemcitabine and cisplatin every three weeks for four cycles prior to surgery.
- Adjuvant: Imfinzi 20 mg/kg every four weeks as a single agent for up to eight cycles after surgery.

See full Prescribing Information for preparation and administration instructions and dosage modifications for adverse reactions.

Contraindications

None listed.

Adverse Reactions

Imfinzi in Combination with Chemotherapy: Most common adverse reactions (≥ 20%) of patients with resectable, Stage II/III NSCLC [neoadjuvant/adjuvant]) are anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash.

Imfinzi as a Single Agent: Most common adverse reactions (≥ 20%) of patients with unresectable, Stage III NSCLC) are cough, fatigue, pneumonitis/radiation pneumonitis, upper respiratory tract infections, dyspnea, and rash.

Imfinzi in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy: Most common adverse reactions (≥ 20%) of patients with metastatic NSCLC) are nausea, fatigue,
musculoskeletal pain, decreased appetite, rash, and diarrhea.

Imfinzi as a Single Agent: Most common adverse reactions (≥ 20%) of patients with limited-stage SCLC) are pneumonitis or radiation pneumonitis, and fatigue.

Imfinzi in Combination with Platinum-Based Chemotherapy: Most common adverse reactions (≥ 20%) of patients with extensive-stage SCLC) are nausea, fatigue/asthenia, and alopecia.

Imfinzi in Combination with Gemcitabine and Cisplatin: Most common adverse reactions (≥ 20%) of patients with BTC) are fatigue, nausea, constipation, decreased appetite, abdominal pain, rash, and pyrexia.

Imfinzi in Combination with Tremelimumab-actl: Most common adverse reactions (≥ 20%) of patients with uHCC) are rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain.

Imfinzi in Combination with Carboplatin and Paclitaxel, followed by IMFINZI as a single agent:
Most common adverse reactions (≥ 20%) of patients with endometrial cancer) were peripheral
neuropathy, musculoskeletal pain, nausea, alopecia, fatigue, abdominal pain, constipation,
rash, decreased magnesium, increased ALT, increased AST, diarrhea, vomiting, cough, decreased
potassium, dyspnea, headache, and increased alkaline phosphatase.

Imfinzi in Combination with Gemcitabine and Cisplatin, followed by IMFINZI as a single agent:
Most common adverse reactions (≥ 20% of patients with MIBC) were decreased hemoglobin,
decreased neutrophils, increased blood creatinine, decreased sodium, nausea, increased ALT,
decreased calcium, decreased platelets, fatigue, increased potassium, decreased lymphocytes,
increased AST, constipation, decreased magnesium, decreased appetite, increased alkaline
phosphate, rash, pyrexia, diarrhea, vomiting and abdominal pain.

Examples of Durvalumab in Guidelines

Systemic Therapy for Small Cell Lung Cancer

American Society of Clinical Oncology (ASCO)
"Patients with LS-SCLC who have completed concurrent chemoradiotherapy and do not have disease progression should be offered consolidation immunotherapy (durvalumab) for up to 2 years if there are no contraindications to immunotherapy."

Prevention, Diagnosis, and Treatment of Hepatocellular Carcinoma

American Association for the Study of Liver Diseases (AASLD)
"Patients with advanced HCC who have Child-Turcotte-Pugh A cirrhosis should be offered atezolizumab plus bevacizumab or durvalumab plus tremelimumab as preferred first-line therapy options."

Systemic Therapy for Advanced Hepatocellular Carcinoma

American Society of Clinical Oncology (ASCO)
"Where there are contraindications to atezo+bev or durva+treme, sorafenib, lenvatinib, or durvalumab may be offered as first-line treatment for patients with Child-Pugh class A, and ECOG PS 0–1 advanced HCC."

Please note: This article is current as of November 5, 2025. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.