The U.S. Food and Drug Administration (FDA) has approved Genentech’s Tecentriq and Tecentriq Hybreza as adjuvant treatments for adults with muscle-invasive bladder cancer who have molecular signs of cancer after bladder removal surgery.
The therapy is approved for patients who have circulating tumor DNA (ctDNA) molecular residual disease (MRD) — fragments of cancer DNA in the bloodstream — following cystectomy, surgery to remove part or all of the bladder. According to a press release from the company, the approval marks the first FDA-approved ctDNA MRD-guided therapy and introduces a new precision medicine approach for individuals with muscle-invasive bladder cancer.
Every year, over 150,000 people across the globe are diagnosed with muscle-invasive bladder cancer. Cystectomy, with or without neoadjuvant therapy, can be curative for some patients, but recurrence remains common. Identifying which patients are most likely to see their cancer return has been a longstanding challenge.
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The FDA approval was supported by results from the Phase III IMvigor011 trial, which evaluated Tecentriq in patients with ctDNA MRD after surgery. The study showed that the therapy reduced the odds of disease recurrence or death in this population by 36% within a year after cystectomy.
Tecentriq, also known as atezolizumab, is an anti-PD-L1 cancer immunotherapy, given via intravenous (IV) infusion. The newly approved indication is the eleventh for the drug in the United States, according to Genentech. Tecentriq Hybreza is a version of the therapy given with an injection.
“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,” Dr. Levi Garraway, chief medical officer and head of Global Product Development at Genentech, said in a statement. “We look forward to delivering this first of its kind ctDNA-guided regulatory approval to bladder cancer physicians and patients in the U.S.”
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