Durvalumab
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| 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