On May 22, 2025, the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending an extension to the marketing authorisation of durvalumab (Imfinzi). This recommendation introduces a new indication for patients with resectable muscle invasive bladder cancer (MIBC), adding to Imfinzi’s growing list of approved uses in various cancers. The updated product information will be published following a final decision from the European Commission.

New Indication for MIBC

The CHMP supports the use of Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi monotherapy as adjuvant treatment after radical cystectomy. This recommendation applies to adult patients with resectable MIBC and aims to improve outcomes by integrating immunotherapy into both pre- and post-surgical phases of treatment.

Imfinzi's Broader Oncology Indications

Imfinzi is already authorised in several cancers, with its use expanding in both monotherapy and combination settings:

Non-Small Cell Lung Cancer (NSCLC):

Imfinzi is used in multiple settings:

With platinum-based chemotherapy as neoadjuvant treatment, followed by monotherapy as adjuvant therapy in resectable NSCLC at high risk of recurrence.

As monotherapy in locally advanced, unresectable NSCLC with PD-L1 expression ≥1%, following chemoradiotherapy.

With tremelimumab and platinum-based chemotherapy as first-line therapy in metastatic NSCLC without EGFR or ALK alterations.

Small Cell Lung Cancer (SCLC):

Imfinzi is approved:

As monotherapy in limited-stage SCLC after platinum-based chemoradiotherapy.

In combination with etoposide and platinum agents (carboplatin or cisplatin) for extensive-stage disease in the first-line setting.

Biliary Tract Cancer (BTC):

Imfinzi combined with gemcitabine and cisplatin is approved for first-line treatment in adults with unresectable or metastatic BTC.

Hepatocellular Carcinoma (HCC):

Imfinzi is used either as monotherapy or in combination with tremelimumab for first-line treatment in adults with advanced or unresectable disease.

Endometrial Cancer:

Imfinzi is approved in combination with carboplatin and paclitaxel as initial therapy for advanced or recurrent endometrial cancer. Maintenance options depend on mismatch repair status:

Monotherapy for mismatch repair-deficient (dMMR) disease.

Combination with olaparib for mismatch repair-proficient (pMMR) disease.

Next Steps

A detailed update to the summary of product characteristics will be published on the EMA website in all EU languages after formal approval by the European Commission. The Commission typically issues its decision within 67 days of the CHMP’s positive opinion.