What Is Durvalumab (Imfinzi)? FDA Approval, Licensing in Turkey, and Reimbursement

• Brand Name: Imfinzi
• Active Ingredient: Durvalumab
• Route of Administration: Administered intravenously (IV).
• Class: Anti PD-L1 monoclonal antibody
• Category: Immune checkpoint inhibitor, immunotherapy
• Manufacturer: MedImmune / AstraZeneca
• Distribution in Turkey: AstraZeneca
• FDA-Approved Cancers:
  • Unresectable stage III non-small cell lung cancer (NSCLC)
  • Metastatic non-small cell lung cancer (NSCLC), in patients without EGFR or ALK mutations
  • Extensive-stage small cell lung cancer (ES-SCLC)
  • Limited-stage small cell lung cancer (LS-SCLC)
  • Metastatic bile duct cancer (cholangiocarcinoma)
  • Hepatocellular carcinoma (HCC)

• May 1, 2017: Imfinzi (durvalumab) received accelerated FDA approval for patients with previously treated advanced bladder cancer .
• February 16, 2018: The FDA approved Imfinzi for unresectable stage III non-small cell lung cancer (NSCLC).
• March 30, 2020: Extensive-stage small cell lung cancer (ES-SCLC) was added as an approved indication for Imfinzi.
• November 20, 2020: Imfinzi was approved for less frequent fixed-dose administration.
• February 22, 2021: The Imfinzi indication for advanced bladder cancer was voluntarily withdrawn.
• September 5, 2022: Imfinzi plus chemotherapy was approved as the first immunotherapy regimen in the United States for patients with advanced bile duct cancer .
• November 11, 2022: Imfinzi and Imjudo, together with chemotherapy, received FDA approval for patients with metastatic non-small cell lung cancer (NSCLC).
• January 10, 2024: Enrollment began in a phase 1b/2 study evaluating Imfinzi with Ampligen for pancreatic cancer treatment.
• June 14, 2024: For primary advanced or recurrent mismatch repair-deficient endometrial cancer , Imfinzi received FDA approval.
• August 16, 2024: Resectable non-small cell lung cancer became an approved indication for Imfinzi use before and after surgery.
• December 4, 2024: It was approved for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease had not progressed after platinum-based chemotherapy and radiotherapy.
• March 28, 2025: The FDA approved Imfinzi (durvalumab) for muscle-invasive bladder cancer (cancer extending into the muscle layer). https://www.drugs.com/newdrugs/fda-approves-imfinzi-durvalumab-muscle-invasive-bladder-cancer-6489.html

• For unresectable or metastatic, PD-L1 ≥ 1%-positive disease (in tumor and/or infiltrating immune cells), adults with biliary tract cancer receive reimbursement for first-line treatment upon issuance of a medical report.

  Explanation: The Institution reimburses treatment with gemcitabine and cisplatin, followed by maintenance monotherapy until progression. With chemotherapy, it is used every 3 weeks for up to 8 cycles; during maintenance monotherapy, up to 1500 mg is given every 4 weeks. If immunotherapy is used in subsequent treatment lines in patients who progress during or after durvalumab, the Institution does not reimburse it.

• For patients with PD-L1 levels of 1% or higher and unresectable stage 3 (according to TNM 7) non-small cell lung cancer, monotherapy is reimbursed upon issuance of a report in adults without progression after platinum-based chemoradiotherapy.

  Explanation: The Institution reimburses use until disease progression, unacceptable toxicity, or a maximum of 12 months in patients without progression. Repeat immunotherapy in subsequent treatment lines after durvalumab is not reimbursed. For nonsquamous metastatic non-small cell lung cancer, the report must state that EGFR, ALK, and ROS mutations are absent. Mutation testing for EGFR, ALK, and ROS is not required in squamous non-small cell lung cancer.

Price: As of June 2026, the pharmacy retail price of an Imfinzi 500 mg vial is 99,990.11 Turkish lira. An Imfinzi 120 mg vial costs 23,989.97 TL.

For the most commonly used 1500 mg every 3 weeks, the approximate cost per cycle is 299,970.33 TL. 

For 10 mg/kg every 2 weeks,  the cost varies with weight (for a 70 kg patient receiving 10 mg/kg, the approximate 28-day cost is 295,940.10 TL).

• It is associated with significant immune-mediated adverse effects due to T-cell activation and proliferation. These immune-mediated reactions can affect any organ system. The most common include pneumonia, enterocolitis, hepatitis, dermatitis, hypophysitis, nephritis, and thyroid dysfunction.
• Mild hepatic impairment does not affect durvalumab pharmacokinetics. However, the effects of moderate or severe hepatic impairment on drug metabolism have not been fully characterized.
• Mild to moderate renal impairment does not affect durvalumab pharmacokinetics. However, the effect of severe renal impairment on drug metabolism is not well defined.
• Durvalumab should be discontinued in the following situations: Grade 2 pneumonia, grade 2 colitis, ALT/AST >3-5 × ULN (upper limit of normal) or total bilirubin >1.5-3 × ULN, serum creatinine >1.5-3 × ULN, or other severe or grade 3 treatment-related toxicity.
• Durvalumab should be permanently discontinued in the following situations: Life-threatening or grade 4 toxicity, grade 4 pneumonia, or grade 4 colitis; ALT/AST >8 × ULN or total bilirubin >5 × ULN; serum creatinine >3-6 × ULN.
• Monitor thyroid and adrenal function before and during treatment.
• Immune-mediated reactions may occur even after treatment is discontinued.
• Durvalumab may harm the fetus. Female patients should therefore use effective contraception during treatment and for at least 3 months after the last dose.
• Breastfeeding is not recommended during treatment or for at least 3 months after the last dose.

1. Fatigue, anorexia, asthenia
2. Pneumonia, shortness of breath, and cough
3. Hepatotoxicity
4. Colitis and abdominal pain
5. Endocrinopathies
6. Neurological toxicity
7. Renal toxicity (nephritis)
8. Skin rashes, dermatitis
9. Infusion reactions
10. Musculoskeletal symptoms