AstraZeneca’s Imfinzi Approved by FDA for BCG-Naïve Non-Muscle-Invasive Bladder Cancer

Editor’s Take: This cancer drug from a major pharma company continues to show efficacy in varied indications.

AstraZeneca’s Imfinzi (durvalumab), combined with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy, gained U.S. FDA approval for another cancer indication.

The treatment now has approval in the United States for adults with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). The FDA’s decision comes from positive results from a Phase III trial (POTOMAC), published in The Lancet.

In 2024, according to AstraZeneca, more than 31,000 people in the U.S. received treatment for high-risk NMIBC. This is typically a curative-intent setting, with a standard-of-care of tumor resection followed by BCG treatment direct to the bladder.

History of Imfinzi in Cancer

Imfinzi is the global standard of care in unresectable, Stage III non-small cell lung cancer (NSCLC). It also has approvals in various combinations for treatment of small cell lung cancer, biliary tract cancer, and hepatocellular carcinoma. Per AstraZeneca, treatment has reached more than 414,000 patients since Imfinzi’s first approval in May 2017.

Most recently, in November 2025, the FDA approved Imfinzi combined with standard-of-care chemotherapy to treat gastric and gastroesophageal junction cancers.

AstraZeneca Reports Positive Trial Results

In the POTOMAC trial, adding one year of Imfinzi treatment to BCG induction and maintenance therapy yielded meaningful results. Statistically, this translated to a 32% reduction in risk of high-risk disease recurrence, progression, or death compared with BCG alone.

Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca, said this early setting reaffirms Imfinzi’s impact in muscle-invasive disease.

“The early and sustained disease-free survival benefit demonstrated by Imfinzi plus BCG is an important advance for patients,” Fredrickson said. “[It] signals a shift in the standard of care.”

Next After FDA Approval

The European Union, Japan, and other countries are currently reviewing regulatory submissions for Imfinzi based on the POTOMAC results.