On 12 October 2023, 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 as follows:
IMFINZI as monotherapy is indicated for the first-line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).
For information, the full indications for Imfinzi will be as follows (new indication in bold):
Non-Small Cell Lung Cancer (NSCLC)
- 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-positive disease.
Small Cell Lung Cancer (SCLC)
- 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 (BTC)
- IMFINZI in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adults with unresectable or metastatic BTC.
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.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available 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.