FDA Approves Atezolizumab for Patients with ctDNA-Positive Muscle-Invasive Bladder Cancer

Clinical Summary:

• Based on results from the phase 3 IMvigor011 trial, the FDA has approved atezolizumab as adjuvant treatment for patients with muscle-invasive bladder cancer with ctDNA molecular residual disease following radical cystectomy.
• In this randomized, double-blind, placebo-controlled study, atezolizumab demonstrated improved disease-free and overall survival, with a safety profile consistent with prior experience. 
• This approval introduces a biomarker-directed adjuvant approach for patients with molecular residual disease, a high-risk population with unmet need following surgery.

On May 15, 2026, the US Food and Drug Administration (FDA) approved adjuvant atezolizumab (Tecentriq, Genentech) and atezolizumab plus hyaluronidase (Tecentriq Hybreza, Genentech) for adult patients with muscle-invasive bladder cancer who have circulating tumor DNA (ctDNA) molecular residual disease following radical cystectomy, as determined by an FDA-authorized test. This approval was based on results from the phase 3 IMvigor011 trial. 

In this double-blind, placebo-controlled trial, 250 patients who underwent radical cystectomy with lymph node dissection and had ctDNA molecular residual disease detected by serial blood testing were randomized 2:1 to receive either 1680 mg of atezolizumab once every 4 weeks or up to 12 cycles of placebo until disease recurrence or unacceptable toxicity. The primary end point was investigator-assessed disease-free survival (DFS). A key secondary end point was overall survival (OS). 

At analysis, median DFS was 9.9 months in the atezolizumab arm and 4.8 months in the placebo arm (hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.47 to 0.87; P = .0047). Median OS was 32.8 months and 21.1 months, respectively (HR, 0.59; 95% CI, 0.39 to 0.90; P = .0131).

The recommended dose of atezolizumab is 840 mg administered intravenously once every 2 weeks, 1200 mg once every 3 weeks, or 1680 mg once every 4 weeks for up to 1 year or until disease recurrence or unacceptable toxicity. The recommended dose of atezolizumab plus hyaluronidase is 1875 mg/30,000 units administered subcutaneously once every 3 weeks for up to 1 year. 

The prescribing information includes warnings for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.

The FDA also approved the Signatera CDx assay (Natera, Inc.) as a companion diagnostic to identify patients eligible for treatment with atezolizumab-based therapy.

Patients with negative Signatera CDx results should continue serial testing until a positive result is detected or until the 12-month testing period is completed.

Source:

US Food and Drug Administration. FDA approves atezolizumab for adjuvant treatment of muscle invasive bladder cancer in patients with molecular residual disease. Accessed on May 15, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-adjuvant-treatment-muscle-invasive-bladder-cancer-patients-molecular