FDA approves Genentech’s Tecentriq for adjuvant muscle-invasive bladder cancer

Genentech, a member of the Roche Group (RHHBY), announced that the U.S. Food and Drug Administration has approved Tecentriq and Tecentriq Hybreza as an adjuvant treatment for adult patients with muscle-invasive bladder cancer who have circulating tumor DNA molecular residual disease after cystectomy, as identified by Natera’s (NTRA) 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.”