FDA approves atezolizumab for adjuvant treatment of muscle invasive bladder cancer in patients with molecular residual disease
On May 15, 2026, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) as adjuvant treatments for adults with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD) as determined by an FDA-authorized test.
Today, the FDA also approved Signatera CDx (Natera, Inc.) as a companion diagnostic device to select patients with MIBC after cystectomy who have ctDNA MRD for adjuvant treatment with Tecentriq or with Tecentriq Hybreza.
Full prescribing information for Tecentriq and Tecentriq Hybreza will be posted on Drugs@FDA .
Efficacy and Safety
Efficacy was evaluated in IMvigor011 (NCT04660344), a multi-center, randomized, double-blind, placebo-controlled trial enrolling 250 patients with MIBC who had radical cystectomy with lymph node dissection and in whom MRD was detected by serial ctDNA MRD evaluation of blood during the subsequent 12 months, starting at least 6 weeks after cystectomy. Patients were randomized (2:1) to receive either atezolizumab 1680 mg or placebo intravenously every four weeks. Treatment continued for up to 12 cycles or one year (whichever occurred first) unless there was disease recurrence or unacceptable toxicity.
The major efficacy outcome measure was investigator-assessed disease-free survival (DFS). Overall survival (OS) was an additional efficacy outcome measure.
A statistically significant improvement in DFS was observed with atezolizumab compared to placebo, with a median DFS of 9.9 months (95% confidence interval [CI]: 7.2, 12.7) for atezolizumab vs. 4.8 months (95% CI: 4.1, 8.3) for placebo (hazard ratio [HR] 0.64 [95% CI: 0.47, 0.87]; p-value 0.0047). A statistically significant improvement in OS was also observed, with a median OS of 32.8 months (95% CI: 27.7, not estimable [NE]) and 21.1 months (95% CI: 14.7, NE) in the respective arms (HR 0.59 [95% CI: 0.39, 0.90]; p-value 0.0131).
The prescribing information for atezolizumab and for atezolizumab and hyaluronidase-tqjs includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.
Recommended Dosage
The recommended atezolizumab dose administered intravenously is 840 mg every two weeks, 1200 mg every three weeks, or 1680 mg every four weeks for up to one year, unless there is disease recurrence or unacceptable toxicity. The recommended dosage of atezolizumab and hyaluronidase-tqjs is 1875 mg of atezolizumab and 30,000 units of hyaluronidase administered subcutaneously every three weeks for up to one year, unless there is disease recurrence or unacceptable toxicity. Patients with negative Signatera CDx test results should continue with serial testing until a positive test result or completion of the recommended 12-month testing window.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
This application was granted priority review. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.
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