Imfinzi - opinion on variation to marketing authorisation
Opinion
EMA has issued an opinion on a change to this medicine's authorisation.
durvalumab
Post-authorisationHuman
On 22 May 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Imfinzi. The marketing authorisation holder for this medicinal product is AstraZeneca AB.
The CHMP adopted a new indication as follows:
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).
For information, the full indications for Imfinzi will be as follows:1
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).
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1New text in bold
CHMP post-authorisation summary of positive opinion for Imfinzi (II-73)
AdoptedReference Number: EMA/162386/2025
English (EN) (169.16 KB - PDF)
First published: