FDA Approves Genentech’s Tecentriq for Adjuvant Muscle-Invasive Bladder Cancer With ctDNA-Guided Treatment
South San Francisco, CA -- May 15, 2026 -- Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today 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.
About the IMVigor011 study
IMvigor011 [NCT04660344] is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with Tecentriq® (atezolizumab) compared with placebo in adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) after cystectomy. ctDNA status was determined using Natera’s Signatera™ technology in the U.S. and in China. The Signatera™ CDx test received simultaneous authorization by the FDA for use as a companion diagnostic to Tecentriq. The surveillance phase of IMvigor011 included 761 people who underwent serial ctDNA testing for up to a year after surgery. Of these, 250 people who tested positive for ctDNA joined the treatment phase, where they received either Tecentriq or placebo. The primary endpoint is investigator-assessed disease-free survival (DFS). Secondary endpoints include overall survival (OS) and tolerability, amongst others.
About Tecentriq® (atezolizumab)
Tecentriq (atezolizumab) is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
About Genentech in cancer immunotherapy
To learn more about Genentech’s scientific-led approach to cancer immunotherapy, please follow this link: https://www.gene.com/cancer-immunotherapy.
About Genentech
Founded 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
Source: Genentech
Source: HealthDay
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Posted : 2026-05-20 16:24
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