Tremelimumab AstraZeneca

Withdrawn

This medicine's authorisation has been withdrawn

tremelimumab

Overview

On 6 November 2023, the European Commission withdrew the marketing authorisation for Tremelimumab AstraZeneca (tremelimumab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, AstraZeneca AB, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Tremelimumab AstraZeneca was granted marketing authorisation in the EU on 20 February 2023 for the treatment of metastatic non-small cell lung cancer (NSCLC). The marketing authorisation was initially valid for a 5-year period. Tremelimumab AstraZeneca contains the same active substance as Imjudo, which is authorised in the EU to treat metastatic NSCLC and advanced or unresectable hepatocellular carcinoma. The marketing authorisation holder will maintain the marketing authorisation for Imjudo. 

The European Public Assessment Report (EPAR) for Tremelimumab AstraZeneca is updated to indicate that the marketing authorisation is no longer valid.

Tremelimumab AstraZeneca : EPAR - Medicine Overview

Reference Number: EMA/3771/2023

Tremelimumab AstraZeneca : EPAR - Risk Management Plan

Product information

Tremelimumab AstraZeneca : EPAR - Product Information

Tremelimumab AstraZeneca : EPAR - All authorised presentations

Product details

• Name of medicine:
  Tremelimumab AstraZeneca
• Active substance:
  Tremelimumab
• International non-proprietary name (INN) or common name:
  tremelimumab
• Therapeutic area (MeSH):
  Carcinoma, Non-Small-Cell Lung
• Anatomical therapeutic chemical (ATC) code:
  L01FX20

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.

Authorisation details

• EMA product number:
  EMEA/H/C/004650
• Marketing authorisation holder:
  AstraZeneca AB

  151 85 Sodertalje; Sweden

• Opinion adopted:
  15/12/2022
• Marketing authorisation issued:
  20/02/2023
• Revision:
  1

Assessment history

Changes since initial authorisation of medicine

Tremelimumab AstraZeneca : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Tremelimumab AstraZeneca : EPAR - Public Assessment Report

AdoptedReference Number: EMA/42903/2023

CHMP summary of positive opinion for Tremelimumab AstraZeneca

AdoptedReference Number: EMA/CHMP/925958/2022