AstraZeneca has fired another volley in its bladder cancer competition with Merck’s Keytruda, with the FDA on Thursday clearing its PD-L1 inhibitor Imfinzi as part of the first immunotherapy combo regimen in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who haven't previously received standard of care Bacillus Calmette-Guérin (BCG) treatment.
The green light clears Imfinzi in the indication alongside BCG induction and maintenance therapy, AZ said in a May 28 release.
This marks the second recent bladder cancer nod for Imfinzi, which was approved in March of last year in muscle invasive bladder cancer (MIBC), in that instance in combination with the chemotherapies gemcitabine and cisplatin ahead of bladder-removing surgery and then on its own following the procedure.
Imfinzi’s latest OK is backed by results from a phase 3 trial in which one year of treatment with the immunotherapy reduced the risk of high-risk disease recurrence, progression or death by 32% when added to BCG induction and maintenance therapy versus BCG alone. With a median follow-up of 61 months, the Imfinzi regimen delivered an early and sustained disease-free survival benefit starting less than four months after beginning treatment, AZ said.
The regimen is the first advancement in treating BCG-naïve, high-risk NMIBC in more than 30 years, according to Neal Shore, M.D., head of the Carolina Urologic Research Center and co-principal investigator in the Imfinzi trial.
“Unfortunately, many of these patients experience disease recurrence requiring repeated surgical procedures, as well as disease progression resulting in surgical removal of their bladder,” Shore said in a statement.
In 2024, more than 31,000 people in the U.S. were treated for high-risk NMIBC, by AstraZeneca's reckoning.
About half of those with NMIBC are at high-risk for disease recurrence or progression based on tumor grade, stage and specific tumor features. Up to 80% of high-risk patients experience disease recurrence within five years of treatment, AZ said.
After AZ gained its initial FDA nod in 2017 for Imfinzi to treat advanced bladder cancer, the company clawed back the approval four years later after the failure of a confirmatory trial. Since then, however, the British pharma has scored in three recent phase 3 bladder cancer trials.
Last week, AZ reported positive results in a study in patients with MIBC who were either ineligible for or had declined cisplatin-based chemotherapy.
In the Volga trial, perioperative treatment with Imfinzi plus neoadjuvant use of Pfizer and Astellas' antibody-drug conjugate Padcev showed significant improvements in event-free survival (EFS) and overall survival (OS) versus standard of care. Patients in the comparator arm had surgery to remove the bladder, with or without approved post-surgical adjuvant treatment.
Imfinzi became a blockbuster in its second full year on the market, and sales continue to scale up. In 2025, it generated $6.1 billion, which marked a 37% year-over-year increase. In the first quarter of 2026, sales for Imfinzi jumped 30% to $1.7 billion.
Meanwhile, Keytruda has been the world’s top-selling cancer drug throughout this decade, generating $32 billion in 2025 and $8 billion in the first quarter of this year.
The FDA endorsed Keytruda in 2023 in combination with Pfizer and Astellas’ Padcev for advanced bladder cancer and, in November of last year, signed off on the combo as perioperative treatment for cisplatin-ineligible patients with MIBC. Keytruda also earned a 2020 nod for BCG unresponsive high-risk NMIBC.