On 22 June 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 tremelimumab (Imjudo).
The marketing authorisation holder for this medicinal product is AstraZeneca AB.
The CHMP adopted a new indication for the treatment of metastatic non-small cell lung cancer (NSCLC).
For information, the full indications for Imjudo will therefore be as follows (new indication in bold):
Imjudo in combination with durvalumab is indicated for the first-line treatment of adults with advanced or unresectable hepatocellular carcinoma.
Imjudo in combination with durvalumab 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.
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.