FDA Approves Genentech’s Tecentriq for Adjuvant Muscle-Invasive Bladder Cancer with ctDNA-Guided Treatment

First approved ctDNA MRD-guided therapy reinforcing Genentech’s commitment to innovation and practice-changing precision medicine
New treatment approach enables healthcare professionals to tailor treatment with the goal of improving clinical benefit and reducing unnecessary intervention
Approval marks the eleventh indication for Tecentriq in the U.S., providing a new option for an aggressive form of cancer

Las Vegas, Nevada (UroToday.com) -- Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) as an adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) after cystectomy, as identified by Natera’s Signatera™ CDx personalized MRD assay.

“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. “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 of the Bladder Cancer Advocacy Network.

The FDA decision was based on positive results from the Phase III IMvigor011 study, which showed that Tecentriq reduced the risk of disease recurrence or death (DFS) by 36% and the risk of death (OS) by 41% in patients with detectable ctDNA MRD identified via serial testing within one year of cystectomy. The safety profile was generally consistent with previous studies of Tecentriq. IMvigor011 is the first prospective Phase III study to demonstrate that a ctDNA-guided approach to adjuvant therapy can significantly improve survival in MIBC.

Each year, over 150,000 people worldwide are diagnosed with MIBC and undergo bladder removal surgery to treat this aggressive disease. Even after surgery, nearly half of these patients see their cancer return. This represents the first approval of a ctDNA-guided therapy, an innovative approach that is currently being investigated in other types of cancer. Historically, doctors have relied on tumor staging to determine who needs treatment after surgery. The IMvigor011 study utilized the Natera Signatera™ personalized ctDNA assay to identify molecular evidence of cancer in the blood, before it becomes visible with standard imaging. This approach enabled adjuvant immunotherapy to be deployed selectively in patients who are at greatest risk of recurrence and most likely to benefit from it, while sparing others without molecular residual disease from the burden of treatment after surgery.

Source: Genentech. (2026). FDA Approves Genentech’s Tecentriq for Adjuvant Muscle-Invasive Bladder Cancer With ctDNA-Guided Treatment [Press release]. https://www.gene.com/media/press-releases/15112/2026-05-15/fda-approves-genentechs-tecentriq-for-ad.

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