Immunotherapy / Oncology

Imfinzi (durvalumab)

AstraZeneca · PD-L1 Immune Checkpoint Inhibitor

FDA Approved 2017 Intravenous (IV) infusion Specialty Medication
Imfinzi durvalumab vial, AstraZeneca

What is Imfinzi? Imfinzi (durvalumab) is a PD-L1 checkpoint inhibitor by AstraZeneca approved for unresectable Stage III NSCLC after chemoradiation, extensive-stage small cell lung cancer, biliary tract cancer, and hepatocellular carcinoma.

About Imfinzi

Brand NameImfinzi
Generic / INNdurvalumab
Drug ClassPD-L1 Immune Checkpoint Inhibitor
ManufacturerAstraZeneca
AdministrationIntravenous (IV) infusion
FDA Approval2017
📦 Available as 120 mg/2.4 mL and 500 mg/10 mL (50 mg/mL) vials.

FDA-Approved Uses for Imfinzi

Indications are based on FDA approval. Your healthcare provider determines appropriate use based on your specific diagnosis, stage, biomarker status, and overall clinical picture.

  • Unresectable Stage III NSCLC — after platinum-based concurrent chemoradiation (consolidation)
  • Extensive-stage small cell lung cancer (ES-SCLC) — first-line with chemotherapy
  • Biliary tract cancer (BTC) — with gemcitabine and cisplatin
  • Hepatocellular carcinoma (HCC) — with tremelimumab (HIMALAYA regimen)
Biomarker Note: No required biomarker for the approved NSCLC consolidation indication. PD-L1 expression was not required for approval in the unresectable Stage III setting.

How Does Imfinzi Work?

Durvalumab binds PD-L1 on tumor cells, blocking its interaction with PD-1 and B7-1 on T cells. This restores T cell-mediated anti-tumor immunity. It does not block the PD-L2/PD-1 interaction, potentially preserving some immune regulation.

Dosage & Administration

NSCLC consolidation: 10 mg/kg IV every 2 weeks or 1500 mg every 4 weeks. ES-SCLC: 1500 mg every 3 weeks (with chemo), then 1500 mg every 4 weeks. Specific regimens vary by indication.

⚠️ Important

Dosing is individualized by the prescribing clinician. Never adjust your dose without consulting your healthcare provider. This information is educational only and does not replace the official prescribing information.

Warnings, Precautions & Side Effects

General Warning

Immune-mediated pneumonitis, hepatitis, colitis, endocrinopathies, nephritis. Infusion-related reactions. Embryo-fetal toxicity.

⛔ Serious Warnings & Precautions
  • Immune-mediated pneumonitis
  • Immune-mediated hepatitis
  • Immune-mediated colitis
  • Infusion-related reactions
  • Embryo-fetal toxicity

Common Side Effects

  • Cough
  • Fatigue
  • Pneumonitis
  • Diarrhea
  • Nausea
  • Rash
  • Infections
  • Dyspnea

This is not a complete list. Always report new or worsening symptoms to your healthcare provider promptly.

Storage & Handling

Refrigerate at 2°C to 8°C (36°F to 46°F). Do not freeze.

BiologicHealthPlus provides temperature-monitored cold-chain specialty delivery for medications requiring refrigeration. Never use a medication if its storage conditions have been compromised.

Insurance Coverage, Prior Authorization & Patient Assistance

🛡️ Commercial Insurance

Imfinzi is covered by most major commercial insurance plans when medically necessary and prior authorized. Coverage tier and cost-sharing vary by plan.

✅ Prior Authorization

Prior authorization is required by virtually all insurance plans for Imfinzi. BiologicHealthPlus handles the complete prior authorization process at no cost to patients or providers.

🏥 Medicare Coverage

Medicare Part B covers this IV medication when administered in a clinical setting. Medicaid coverage varies by state.

🆓 Patient Assistance

Manufacturer patient assistance programs may be available for eligible uninsured or underinsured patients. Contact BiologicHealthPlus for a confidential eligibility review.

Prior Authorization Patient Assistance Insurance & Savings Medication Costs

Frequently Asked Questions — Imfinzi

Imfinzi (durvalumab) is a PD-L1 checkpoint inhibitor by AstraZeneca, best known as the standard of care consolidation therapy for unresectable Stage III NSCLC after concurrent chemoradiation (the PACIFIC regimen).

PACIFIC refers to the landmark trial showing that 12 months of durvalumab consolidation after chemoradiation significantly improved progression-free and overall survival in Stage III NSCLC without progression after chemoradiation.

Imfinzi is covered by Medicare Part B and commercial insurance with prior authorization for approved indications.

Related Medications

Imjudo (tremelimumab — HCC combination)  ·  Keytruda (pembrolizumab)  ·  Tecentriq (atezolizumab)

Related Conditions

Stage III NSCLC  ·  Small cell lung cancer  ·  Biliary tract cancer  ·  Hepatocellular carcinoma

Comparisons

Keytruda Tecentriq

Authoritative References

Medical Disclaimer: This page is for general educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult your oncologist, hematologist, or licensed healthcare professional before making any treatment decisions. Last reviewed: August 2026 by the BiologicHealthPlus Clinical Team.