New Imfinzi FDA application gets priority review, decision expected in fourth quarter
Key Facts
AstraZeneca said the U.S. Food and Drug Administration accepted its application for priority review of Imfinzi in combination with enfortumab vedotin to treat patients with muscle-invasive bladder cancer who are ineligible for or refuse cisplatin-based treatment. The company said on September 25, 2026, that a regulatory decision on the application is expected in the fourth quarter of 2026. This means the application is undergoing priority regulatory review; the announcement does not represent final approval for the new use. The filing is based on results from the VOLGA trial, according to the company. In the United States, the FDA had previously approved Imfinzi in May 2026 in a different combination with BCG, for patients with high-risk non-muscle-invasive bladder cancer.
The new review targets patients with muscle-invasive cancer who are not suited to cisplatin-based chemotherapy. AstraZeneca said about one in four people with bladder cancer have muscle-invasive disease. The company estimated that up to 50% of these patients are ineligible for cisplatin-based treatment because of impaired kidney function or comorbidities. Susan Galbraith, the company’s executive vice president of oncology and hematology research and development, said the priority review “strengthens the potential for Imfinzi to become the backbone immunotherapy for muscle-invasive bladder cancer.” She added that patients face high rates of disease recurrence despite bladder-removal surgery. This remains the company’s description of the rationale for the application, not a decision by the regulator.
In the planned interim analysis of the VOLGA trial, AstraZeneca said the Imfinzi combination reduced the risk of disease progression, recurrence, failure to undergo surgery or death by 49% compared with the control group. The event-free survival hazard ratio was 0.51, while median event-free survival had not yet reached an estimable point in the treatment group. In the control group, the median was 12.1 months. The company also said the combination reduced the risk of death by 42% in the interim analysis. The proportion of patients alive after two years was 78% in the treatment group, compared with 69% in the control group, while median overall survival had not reached the estimated threshold in either group.
These results and the current application differ from the earlier U.S. approval of Imfinzi with BCG. On May 28, 2026, the FDA approved durvalumab, the generic name for Imfinzi, with BCG for adults who had not previously received BCG and had high-risk non-muscle-invasive bladder cancer. The approval was based on the POTOMAC trial, which included 1,018 patients after transurethral resection of the tumor. The study randomized participants in a 1:1:1 ratio among the durvalumab and BCG combination, BCG alone, and an additional investigational combination regimen. Disease-free survival was the primary efficacy endpoint, and the FDA found a statistically significant improvement for the combination compared with BCG alone, with a hazard ratio of 0.68, a 95% confidence interval between 0.50 and 0.93, and a p-value of 0.0154.
In another part of the company’s bladder cancer program, AstraZeneca reported in July 2026 that preliminary results from the phase III NILE trial showed a statistically significant and clinically meaningful improvement in overall survival with Imfinzi plus chemotherapy. The results involved patients with unresectable advanced or metastatic urothelial cancer and high PD-L1 levels. They concern a different combination and patient population from the VOLGA application under review. The company also said regulatory applications for the treatment based on VOLGA results were under review in the European Union, Japan and other countries. The next U.S. milestone remains the FDA decision expected in the fourth quarter of 2026.