FDA Approves First ctDNA-Guided Therapy: Tecentriq with Signatera CDx for Adjuvant Treatment of Muscle-Invasive Bladder Cancer

May 16, 2026 16:42 CST Updated 16:42

Genentech

Pharmaceutical R&D Manufacturer

Natera

Clinical DNA Testing Provider

The U.S. Food and Drug Administration (FDA) recently approvedGenentechCheckpoint InhibitorsTecentriqAnd its subcutaneous injection formulation Tecentriq Hybreza, asMuscle-invasive Bladder CancerAdjuvant treatment for patients. Applicable to patients who, after cystectomy, throughNateraTheSignatera CDxPersonalized Molecular Residual Disease Detection, Determine ItsCirculating Tumor DNAPositive individuals.

Genentech and Natera both refer to this asHistoric Milestone in Precision Medicine. This is the first approval by the FDActDNA MRD-Guided TherapySignatera has also received FDA authorization as a companion diagnostic test to identify ctDNA-positive patients who may benefit from Tecentriq treatment, which is also the first of its kind approved by the FDA.First Approval of Blood-Based MRD Test as a Companion Diagnostic。

Avoid OverDegreeTreatment

Signatera Test Results After CystectomyPositivePatients may be suitable for Tecentriq treatment; while the result isNegativeFor patients, it may be safely possible to avoid treatment. Traditionally, doctors have relied on tumor staging to decide which patients need to receive treatment after surgery.

Significant extension of survival period

This approval is based onPhase III IMvigor011 TrialThe results. The trial enrolled 250 MIBC patients who were Signatera ctDNA positive post-cystectomy but had no radiographic evidence of disease, and they were randomized to receive Tecentriq or placebo.

Results showed that patients receiving Tecentriq treatmentDisease-free Survival PeriodNearly twice that of the placebo group (9.9 months vs 4.8 months). The Tecentriq groupMedian Overall SurvivalIt was also significantly longer (32.8 months vs 21.1 months). At two years, 62.8% of patients in the Tecentriq group were alive, compared to 46.9% in the placebo group.

Notably, at the two-year mark,97%Patients with negative Signatera test results remained alive without receiving adjuvant therapy.

Initiate a New Paradigm of Treatment

Genentech Chief Medical Officer and Head of Global Product Development Levi Garraway said, "Combining our cancer immunotherapy Tecentriq with advanced MRD testing allows for more precise identification of patients in need of intervention, as well as those who may safely avoid unnecessary treatment. We look forward to bringing this first-of-its-kind ctDNA-guided regulatory approval to bladder cancer doctors and patients in the United States."

Thomas Powles, Chair of Barts Cancer Center at St. Bartholomew's Hospital and principal investigator of the IMvigor011 trial, stated: "Historically, we have relied on imaging to determine whether cancer has recurred, but that also means there are already millions of cancer cells in the body. As we have seen in IMvigor011 and several other trials, Signatera detects tumor DNA at an earlier time point, providing us with a crucial advantage to improve patient outcomes."

Solomon Moshkevich, President of Natera's Clinical Diagnostics Division, stated that the FDA approval of Signatera CDx is "a significant milestone in the field of precision oncology and personalized medicine," and "validates the vision Natera put forward a decade ago, solidifying Signatera MRD as the new standard of care for muscle-invasive bladder cancer."

Analysts pointed out that this approval may prompt the National Comprehensive Cancer Network (NCCN) to review the IMvigor011 trial data and include Tecentriq with Signatera CDx in clinical guidelines, thereby promoting commercial insurance coverage for Signatera testing in this indication.