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FDA Approves First Blood-Test-Guided Bladder Cancer Immunotherapy, Using DNA in the Blood to Decide Who Needs Treatment

The US Food and Drug Administration approved Genentech's Tecentriq Hybreza on May 15, 2026, making it the first cancer immunotherapy whose use is guided by a circulating tumor DNA blood test after surgery. Patients with muscle-invasive bladder cancer who test positive for residual cancer DNA in their blood after removal of the bladder receive the drug as an injection rather than a long intravenous infusion. In the IMvigor011 clinical trial, the approach reduced the risk of cancer recurrence or death by 36 percent and the risk of death alone by 41 percent.