# Durvalumab

Durvalumab (Imfinzi, AstraZeneca AB) has 16 EU-approved indications in 7 tumour types. 2 need a biomarker result: MMR/MSI (1) and PD-L1 (1).

## Approved indications

### Small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + etoposide and either carboplatin or cisplatin | 1st line, advanced | - |
| None | Monotherapy | Consolidation, locally advanced | After platinum-based chemoradiation therapy without progression |

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| EGFR/ALK negative | + platinum-based chemotherapy | Neoadjuvant, early | Then adjuvant monotherapy after surgery; High risk of recurrence |
| EGFR/ALK negative | Monotherapy | Adjuvant, early | After neoadjuvant durvalumab + platinum-based chemotherapy and surgical resection; High risk of recurrence |
| No sensitising EGFR mutations or ALK positive mutations | + tremelimumab and platinum-based chemotherapy | 1st line, metastatic | - |
| TPS ≥ 1%, tumours express PD-L1 on ≥ 1% of tumour cells | Monotherapy | Consolidation, locally advanced | After platinum-based chemoradiation therapy without progression |

### Gastric and GEJ adenocarcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + FLOT chemotherapy | Neoadjuvant, early | Then adjuvant durvalumab + FLOT chemotherapy, followed by monotherapy after surgery |
| None | + FLOT chemotherapy, followed by monotherapy | Adjuvant, early | After neoadjuvant durvalumab + FLOT chemotherapy and surgical resection |

### Hepatocellular carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + tremelimumab | 1st line, advanced | - |
| None | Monotherapy | 1st line, advanced | - |

### Biliary tract cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + gemcitabine and cisplatin | 1st line, advanced | - |

### Endometrial cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + carboplatin and paclitaxel | 1st line, advanced | Then maintenance (see the maintenance entries); Candidates for systemic therapy |
| Mismatch repair proficient (pMMR) | + olaparib | Maintenance, advanced | After first-line durvalumab + carboplatin and paclitaxel without progression; Candidates for systemic therapy |
| Mismatch repair deficient (dMMR) | Monotherapy | Maintenance, advanced | After first-line durvalumab + carboplatin and paclitaxel without progression; Candidates for systemic therapy |

### Urothelial carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + gemcitabine and cisplatin | Neoadjuvant, early | Muscle-invasive only; Then adjuvant monotherapy after surgery |
| None | Monotherapy | Adjuvant, early | Muscle-invasive only; After neoadjuvant durvalumab + gemcitabine and cisplatin and radical cystectomy |

## Products

### Imfinzi

- Company: AstraZeneca AB
- Target: PD-L1 inhibitor (antibody)
- Class: PD-1/PD-L1 (programmed cell death protein 1/death ligand 1) inhibitors
- ATC: L01FF03
- EU approval: 21 Sep 2018
- Label revised: 18 May 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/imfinzi-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/imfinzi

Mechanism (SmPC section 5.1): Durvalumab selectively blocks PD-L1 interaction with PD-1 and CD80, releasing inhibition of T-cell activation and enhancing antitumour immune responses.

## Label wording

- **Durvalumab** (Imfinzi), Non-small cell lung cancer, neoadjuvant, early: “IMFINZI in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements (for selection criteria, see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Non-small cell lung cancer, adjuvant, early: “IMFINZI in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements (for selection criteria, see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Non-small cell lung cancer, consolidation, locally advanced: “IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Non-small cell lung cancer, 1st line, metastatic: “IMFINZI in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Small cell lung cancer, consolidation, locally advanced: “IMFINZI as monotherapy is indicated for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Small cell lung cancer, 1st line, advanced: “IMFINZI in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Biliary tract cancer, 1st line, advanced: “IMFINZI in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adults with unresectable or metastatic biliary tract cancer (BTC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Hepatocellular carcinoma, 1st line, advanced: “IMFINZI as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Hepatocellular carcinoma, 1st line, advanced: “IMFINZI in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Endometrial cancer, 1st line, advanced: “IMFINZI in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Endometrial cancer, maintenance, advanced: “IMFINZI as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Endometrial cancer, maintenance, advanced: “IMFINZI in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Urothelial carcinoma, neoadjuvant, early: “IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Urothelial carcinoma, adjuvant, early: “IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Gastric and GEJ adenocarcinoma, neoadjuvant, early: “IMFINZI in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant IMFINZI monotherapy, is indicated for the treatment of adults with resectable gastric or gastro-oesophageal junction adenocarcinoma.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Gastric and GEJ adenocarcinoma, adjuvant, early: “IMFINZI in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant IMFINZI monotherapy, is indicated for the treatment of adults with resectable gastric or gastro-oesophageal junction adenocarcinoma.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/durvalumab