FDA approves atezolizumab for adjuvant treatment of muscle invasive bladder cancer in patients with molecular residual disease
Regulatory approval: On May 15, 2026, the FDA approved atezolizumab (Tecentriq) and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) as adjuvant treatment for adults with muscle-invasive bladder cancer after cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD) identified by an FDA-authorized test. Approval was supported by IMvigor011, which showed statistically significant improvements in disease-free and overall survival versus placebo in ctDNA MRD–positive patients.
FDA regulatory approval (May 15, 2026)
The FDA approved atezolizumab (Tecentriq) and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for adjuvant treatment of adults with muscle-invasive bladder cancer (MIBC) after cystectomy who have ctDNA molecular residual disease (MRD) as determined by an FDA-authorized test.
The FDA also approved Signatera CDx (Natera) as a companion diagnostic to select patients with MIBC after cystectomy who have ctDNA MRD for adjuvant treatment with Tecentriq or Tecentriq Hybreza.
Supporting evidence
Efficacy and safety were evaluated in IMvigor011 (NCT04660344), a multi-center, randomized, double-blind, placebo-controlled trial (n=250) enrolling patients with MIBC who had radical cystectomy with lymph node dissection and MRD detected by serial ctDNA MRD blood testing during the subsequent 12 months (starting ≥6 weeks post-cystectomy). Patients were randomized 2:1 to atezolizumab 1680 mg IV every 4 weeks or placebo for up to 12 cycles/1 year.
- Disease-free survival (DFS): median 9.9 vs 4.8 months (HR 0.64; 95% CI 0.47–0.87; p=0.0047).
- Overall survival (OS): median 32.8 vs 21.1 months (HR 0.59; 95% CI 0.39–0.90; p=0.0131).
Label warnings/precautions include immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.