Genentech announced FDA approval of Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) as an adjuvant treatment for muscle-invasive bladder cancer (MIBC) on May 15th, 2026. The treatment is indicated for adult patients who have circulating tumor DNA (ctDNA) molecular residual disease (MRD) after cystectomy.

Atezolizumab is a monoclonal antibody designed to bind with PD-L1 and block its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, the treatment aims to enable the reactivation of T-cells. It is the first ctDNA MRD-guided therapy approved by FDA, according to the release.

FDA approval was based on results from the Phase III IMvigor011 study, which evaluated atezolizumab in adult patients with MIBC who have ctDNA MRD after cystectomy. Relative to patients given placebo, the treatment group had a 36% reduced risk of disease recurrence or death and 41% reduced risk of death, according to the release.

“Combining our cancer immunotherapy Tecentriq with state-of-the-art MRD testing allows more precise identification of patients who are candidates for intervention and those who might safely avoid unnecessary treatment,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development, Genentech, in the release. “We look forward to delivering this first of its kind ctDNA-guided regulatory approval to bladder cancer physicians and patients in the U.S.”

“For the patients and families, the ‘watch and wait’ period after a cystectomy is often defined by uncertainty. This ctDNA-guided approach can enable doctors to use serial ctDNA MRD testing to identify who is at a higher risk of recurrence and move quickly toward immunotherapy for those who may benefit from it, while allowing others to safely avoid additional treatment and its associated side effects,” said Meri-Margaret Deoudes, CEO, Bladder Cancer Advocacy Network, in the release.