Withdrawal of EMA application for the use of Imfinzi (durvalumab) + BCG in the treatment of high-risk non-muscle invasive bladder cancer (NMIBC) – AstraZeneca

AstraZeneca withdrew its application for the use of Imfinzi (durvalumab) in combination with BCG in the treatment of high-risk non-muscle invasive bladder cancer (NMIBC), a type of cancer that affects the lining of the bladder. The company withdrew the application on 24 June 2026.

Imfinzi has been authorised in the EU since September 2018. It contains the active substance durvalumab and is given by infusion (drip) into a vein. The company applied for an extension of indication to add the treatment of high-risk non-muscle invasive bladder cancer (NMIBC), where the cancer has not spread into the muscle layer but is at high risk of coming back or spreading beyond the inner lining. It was to be used with Bacillus Calmette-Guérin (BCG; a standard bladder cancer treatment that stimulates the immune system) in patients who had not received BCG before.

The company presented the results of a main study involving 679 patients with high-risk NMIBC who had not received BCG before. They received either Imfinzi plus BCG or BCG only. The main measure of effectiveness was the time people lived without detectable signs of the disease. The application was withdrawn after the European Medicines Agency had evaluated the initial information from the company and had prepared questions for the company. After the Agency had assessed the company’s responses to the questions, there were still some unresolved issues.

Based on the review of the information and the company’s responses to the Agency’s questions, at the time of the withdrawal, the Agency had some concerns and its provisional opinion was that Imfinzi could not have been authorised for the treatment of high-risk NMIBC. The Agency considered that the benefits of adding Imfinzi to BCG in patients with high-risk NMIBC do not outweigh the risks. Although the combination of Imfinzi and BCG was shown to prolong the time people lived without detectable signs of disease, the clinical relevance of the observed effect was uncertain. In addition, there were some limitations in the study design that affected the interpretation of the results. The Agency considered that the observed effect does not outweigh the side effects associated with Imfinzi, which are significantly greater than those with BCG alone.

Therefore, at the time of the withdrawal, the Agency’s opinion was that the benefits of Imfinzi in the treatment of high-risk NMIBC did not outweigh its risks. In its letter notifying the Agency of the withdrawal of application, the company stated that it withdrew its application based on the feedback from the Agency indicating that it would not be able to conclude that the benefits outweigh the risks based on the data provided.