Imfinzi - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

durvalumab

Opinion

On 12 October 2023, 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:

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 follows¹:

Non-Small Cell Lung Cancer (NSCLC)

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 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).

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), 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.

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1 New text in bold

CHMP post-authorisation summary of positive opinion for Imfinzi (II-57)

AdoptedReference Number: EMA/272025/2023

Key facts

• Name of medicine:
  Imfinzi
• EMA product number:
  EMEA/H/C/004771
• Active substance:
  durvalumab
• International non-proprietary name (INN) or common name:
  durvalumab
• Therapeutic area (MeSH):
  Carcinoma, Non-Small-Cell Lung
• Anatomical therapeutical chemical (ATC) code:
  L01XC28
• Marketing authorisation holder:
  AstraZeneca AB
• Date of opinion:
  12/10/2023
• Status:
  Positive