The use of AstraZeneca’s Imfinzi (durvalumab) is now approved in the European Union (EU) in combination with chemotherapy. As reported in Pharmabiz.com, the combination treatment is now approved for adults living with non-small cell lung cancer (NSCLC) who are at high risk of reoccurrence and do not have epidermal growth factor receptor mutations, or EGFR, or anaplastic lymphoma kinase rearrangements, or ALK.
The European Commission approved Imfinzi after the Committee of Medical Products for Human Use provided a positive opinion based on the results of the AEGEAN trials.
Results of the trials indicated a 32% overall reduction in the risk of recurrence, progression events or death when compared to patients who received chemotherapy treatment only.
Imfinzi has already been approved in the United States, China and multiple other countries based on the results of the AEGEAN trials. Additional countries are currently seeking approval as well.
Lung cancer makes up approximately one-fifth of all cancers in men and women and is the leading cause of cancer deaths.
Imfinzi is a human immunoglobulin GI kappa monoclonal antibody that blocks the interaction of specific PD-L and CD-80 proteins in cancerous tumors that attack cell immunity.
Imfinzi is also approved for metastatic NSCLS in combination with chemotherapy and Imjudo (tremelimumab), for patients with small cell lung cancer (SCLC) where the disease has not progressed after concurrent platinum-based CRT, and for patients with extensive-stage SCLC in combination with chemotherapy.
Imfinzi is approved for advanced or metastatic biliary tract cancer in combination with chemotherapy and for hepatocellular carcinoma (HCC) in combination with Imjudo, and as a monotherapy for HCC in Japan and the EU only.
Imfinzi can also be used to treat muscle invasive bladder cancer in the U.S. and has recently met primary endpoints in the MATTERHORN phase III trial for gastric and gastroesophageal junction cancers for combination use. It is also currently being tested for single use and in combination with alternative cancer therapies for SCLC, NSCLC, bladder, breast, gastrointestinal and gynecological cancers.
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AstraZeneca cancer research cancer treatment Imfinzi non-small cell lung cancer NSCLC
Last modified: April 7, 2025
