Tremelimumab AstraZeneca

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Assessment Report (EPAR) for Tremelimumab AstraZeneca is updated to indicate that the marketing authorisation is no longer valid.