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 of Durvalumab
Biomarker requirementRegimenSettingConditions
Small cell lung cancer2
None
+ etoposide and either carboplatin or cisplatin
1L
advanced
None
None
Monotherapy
Consol.
locally adv.
After platinum-based chemoradiation therapy without progression
Non-small cell lung cancer4
EGFR/ALK negative
+ platinum-based chemotherapy
Neoadj.
early
Then adjuvant monotherapy after surgery; High risk of recurrence
EGFR/ALK negative
Monotherapy
Adj.
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
1L
metastatic
None
TPS ≥ 1%, tumours express PD-L1 on ≥ 1% of tumour cells
Monotherapy
Consol.
locally adv.
After platinum-based chemoradiation therapy without progression
Gastric and GEJ adenocarcinoma2
None
+ FLOT chemotherapy
Neoadj.
early
Then adjuvant durvalumab + FLOT chemotherapy, followed by monotherapy after surgery
None
+ FLOT chemotherapy, followed by monotherapy
Adj.
early
After neoadjuvant durvalumab + FLOT chemotherapy and surgical resection
Hepatocellular carcinoma2
None
+ tremelimumab
1L
advanced
None
None
Monotherapy
1L
advanced
None
Biliary tract cancer1
None
+ gemcitabine and cisplatin
1L
advanced
None
Endometrial cancer3
None
+ carboplatin and paclitaxel
1L
advanced
Then maintenance (see the maintenance entries); Candidates for systemic therapy
Mismatch repair proficient (pMMR)
+ olaparib
Maint.
advanced
After first-line durvalumab + carboplatin and paclitaxel without progression; Candidates for systemic therapy
Mismatch repair deficient (dMMR)
Monotherapy
Maint.
advanced
After first-line durvalumab + carboplatin and paclitaxel without progression; Candidates for systemic therapy
Urothelial carcinoma2
None
+ gemcitabine and cisplatin
Neoadj.
early
Muscle-invasive only; Then adjuvant monotherapy after surgery
None
Monotherapy
Adj.
early
Muscle-invasive only; After neoadjuvant durvalumab + gemcitabine and cisplatin and radical cystectomy
Full text of section 4.1 (therapeutic indications)

Non-Small Cell Lung Cancer (NSCLC) 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). 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). 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. Small Cell Lung Cancer (SCLC) 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. 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). Biliary Tract Cancer (BTC) IMFINZI in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adults with unresectable or metastatic biliary tract cancer (BTC). Hepatocellular Carcinoma (HCC) IMFINZI as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). IMFINZI in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). Endometrial Cancer 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, followed by maintenance treatment with: • IMFINZI as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR) • IMFINZI in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR). Muscle Invasive Bladder Cancer (MIBC) 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). Gastric or Gastro-oesophageal Junction Adenocarcinoma (GC/GEJC) 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.

Label history

40 changes to the Imfinzi label since 2020, 10 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes