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EMA Product

Imjudo

Product approved by European Medicines Agency (EU)

Basic Information

Imjudo

Regulatory Information

EMEA/H/C/006016

Authorised

February 20, 2023

December 15, 2022

8

December 12, 2024

Company Information

Sweden

151 85 Sodertalje

ASTRAZENECA AB

Drug Classification

Additional Monitoring

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). Imjudo 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.

Overview Summary

Imjudo is a cancer medicine. It is used to treat: - hepatocellular carcinoma (a type of liver cancer) in adult patients who have not been treated before and whose disease is advanced or unresectable (cannot be removed by surgery). It is used in combination with durvalumab, another cancer medicine; - non-small cell lung cancer (NSCLC) that has metastasised (spread to other parts of the body) in adult patients who have not been treated before. It is given together with durvalumab and platinum-based chemotherapy and is used when the cancer has shown no mutations (changes) in the so-called EGFR and ALK Imjudo contains the active substance tremelimumab.

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