Imfinzi received approval in the U.S., becoming the first and only immuno-combination therapy for BC

On May 28, 2026, AstraZeneca announced that its immunotherapy drug Imfinzi (durvalumab) in combination with BCG (Bacillus Calmette-Guérin) induction and maintenance regimen has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with BCG-naive high-risk non-muscle-invasive bladder cancer (NMIBC). This is the first new combination therapy approved for this patient population in more than three decades, marking a significant step forward in the treatment landscape of high-risk NMIBC.

Bladder cancer is the ninth most common malignancy worldwide, with more than 614,000 new cases diagnosed each year. Over 70% of patients are initially diagnosed with non-muscle-invasive bladder cancer, meaning the tumor remains confined to the inner surface tissue of the bladder without invading the muscle layer. However, approximately half of these patients are classified as high-risk due to tumor grade, stage, and other characteristics, facing extremely high rates of recurrence and progression. Data show that up to 80% of high-risk patients experience disease recurrence within five years of treatment, and repeated surgeries or eventual bladder removal impose a heavy physical and emotional burden on patients.

This approval is based on positive results from the Phase III clinical trial called POTOMAC. The trial enrolled BCG-naive patients with high-risk NMIBC and had a median follow-up of more than five years (60.7 months). Results showed that compared to BCG alone, adding one year of Imfinzi to BCG induction and maintenance therapy reduced the risk of high-risk disease recurrence, progression, or death by 32% (hazard ratio for disease-free survival [DFS] = 0.68, p = 0.0154). The combination therapy demonstrated early and durable DFS benefit less than four months after treatment initiation, and the estimated median DFS was not reached in either arm. The data were presented at the 2025 European Society for Medical Oncology (ESMO) Congress and simultaneously published in The Lancet.

Dr. Neal Shore, co-lead principal investigator of the POTOMAC trial and Director of START Carolinas, stated, "Sadly, many patients with high-risk NMIBC experience disease recurrence, requiring repeated surgeries and even progression to bladder removal. The POTOMAC trial showed that durvalumab plus BCG reduced the risk of recurrence, progression, or death by nearly one-third, representing one of the most significant advances in this field in over three decades."

Regarding safety, the Imfinzi plus BCG regimen was consistent with the known safety profiles of each agent, with no new safety signals identified. The addition of Imfinzi did not affect patients' ability to complete the full course of BCG therapy nor had a meaningful negative impact on quality of life. Regulatory submissions based on the POTOMAC results are ongoing in multiple countries and regions, including the European Union and Japan.

Dave Fredrickson, Executive Vice President of AstraZeneca's Oncology Hematology Business Unit, noted, "This approval brings the first immuno-oncology combination therapy to BCG-naive high-risk NMIBC patients in the U.S., further reinforcing the value of Imfinzi in early-stage bladder cancer. We believe this will drive a shift in the standard of care." Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network, emphasized, "New effective treatment options are always urgently needed. Today's approval brings truly meaningful hope to patients and their families."

Notably, Imfinzi has also achieved successive successes in muscle-invasive bladder cancer (MIBC). The Phase III VOLGA trial, announced last week, showed that perioperative use of Imfinzi plus neoadjuvant enfortumab vedotin significantly improved event-free survival and overall survival in MIBC patients who are ineligible for or refuse cisplatin-based chemotherapy. Additionally, based on the Phase III NIAGARA trial, Imfinzi has been approved in many countries outside the U.S. for MIBC patients eligible for cisplatin-based therapy.

From non-muscle-invasive to muscle-invasive disease, Imfinzi is progressively building an evidence chain for immunotherapy across different stages of bladder cancer, bringing new hope for cure and long-term survival to more patients.