AstraZeneca Gains FDA Approval for Durvalumab Plus BCG in BCG-Naïve High-Risk NMIBC

AstraZeneca's Imfinzi (durvalumab) now carries an approved indication in combination with Bacillus Calmette-Guérin for BCG-naïve, high-risk non-muscle invasive bladder cancer, a label change that will require manufacturers, pharmacovigilance teams, and site-level QA functions to absorb a revised prescribing framework before commercial distribution begins.

The FDA approval, dated May 28, 2026, was supported by the POTOMAC study (NCT03528694), a randomized, open-label, multicenter trial enrolling 1,018 patients with high-risk NMIBC following transurethral resection of bladder tumor. Patients were randomized 1:1:1 across three arms; the primary efficacy comparison was durvalumab every four weeks for 13 cycles plus BCG induction and maintenance versus BCG induction and maintenance alone. The major efficacy outcome, investigator-assessed disease-free survival, showed a statistically significant improvement in the combination arm (hazard ratio 0.68 [95% CI: 0.50, 0.93]; two-sided p-value 0.0154), with median DFS not reached in either arm.

For regulatory affairs leads, the prescribing information carries four warning and precaution categories that will anchor post-market safety monitoring obligations: immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicities. Each category has direct implications for MedWatch adverse event reporting workflows and CAPA documentation at dispensing and infusion sites operating under 21 CFR Part 211 and institutional pharmacovigilance SOPs.

The recommended dose for patients weighing 30 kg or above is 1,500 mg every four weeks for a maximum of 13 cycles, administered alongside BCG induction and maintenance. Treatment discontinuation criteria include high-risk disease recurrence, progression, or unacceptable toxicity. The application received standard review and used the FDA's voluntary Assessment Aid to facilitate agency evaluation; no expedited program designation applied.

Full prescribing information will be posted to Drugs@FDA, and QA and regulatory teams should treat that posting as the authoritative reference for label reconciliation against any existing Imfinzi site documentation.

Source: FDA Drugs@FDA / What's New: Drugs RSS Feed, May 28, 2026.