On 27 February 2025, the European Medicines Agency’s (EMA’s) 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 durvalumab (Imfinzi).
The marketing authorisation holder for this medicinal product is AstraZeneca AB.
The CHMP adopted a new indication to include treatment of adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence.
The full indications for Imfinzi will therefore be as follows (new indication in bold):
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.
- IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable NSCLC in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy.
- 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 alterations.
Small Cell Lung Cancer (SCLC)
- IMFINZI as monotherapy is indicated for the treatment of adults with limited-stage 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 SCLC.
Biliary Tract Cancer
- IMFINZI in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer.
Hepatocellular Carcinoma (HCC)
- IMFINZI as monotherapy is indicated for the first line treatment of adults with advanced or unresectable HCC.
- IMFINZI in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable 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
- IMFINZI in combination with olaparib in endometrial cancer that is mismatch repair proficient.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, 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.
Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.