AstraZeneca (LSE:AZN) said the FDA approved Imfinzi in combination with BCG induction and maintenance therapy for adult patients with BCG‑naïve, high‑risk non‑muscle‑invasive bladder cancer.
"The durvalumab plus BCG regimen is the first new therapy approved in over 30 years for patients with BCG‑naïve, high‑risk non‑muscle‑invasive bladder cancer," Neal Shore, co‑principal investigator in POTOMAC, said.
The approval rests on POTOMAC, where adding one year of Imfinzi to BCG reduced the risk of high‑risk disease recurrence, progression or death by 32% versus BCG alone (disease‑free survival hazard ratio 0.68; 95% CI 0.50-0.93; p=0.0154) with median follow‑up of 60.7 months and an early, sustained DFS benefit beginning within four months.
The randomised, open‑label Phase III trial enrolled 1,018 patients across more than 120 centres in 12 countries and compared Imfinzi plus BCG induction and maintenance, Imfinzi plus BCG induction only, and BCG induction and maintenance alone.
Safety for Imfinzi plus BCG was consistent with the known profiles of the individual medicines, with no new safety signals, no meaningful impact on patient‑reported quality of life and no compromise to completing BCG therapy.
AstraZeneca noted that more than 31,000 people in the US were treated for high‑risk NMIBC in 2024 and that up to 80% of high‑risk patients experience recurrence within five years, highlighting the clinical need this approval addresses.
Regulatory submissions based on POTOMAC are under review in the EU, Japan and several other countries.
