The FDA has now approved them to treat muscle-invasive bladder cancer (MIBC) in adults after surgery (cystectomy) when circulating tumor DNA (ctDNA) is detected, indicating molecular residual disease (MRD), on an FDA-authorized blood test.
The FDA has also cleared Signatera CDx, a test used to detect ctDNA and help identify patients who may benefit from treatment with these medicines.
MIBC is an aggressive cancer, with more than 150,000 people worldwide getting bladder removal surgery to treat it, yet it recurs in nearly half of them.
Tecentriq is a lab-made antibody that works by blocking programmed death-ligand 1 (PD-L1), a protein that cancer cells use to hide from your immune system. When PD‑L1 is blocked, your T cells (a type of immune cell) can more easily see and attack cancer cells. But because PD-L1 is also on normal cells, Tecentriq can affect those cells as well. Tecentriq is given intravenously (as an IV), whereas another form of the same medicine, Tecentriq Hybreza, is given as an under‑the‑skin shot, also called a subcutaneous (SC) injection. This approval matters because it reduces the concern that patients and families face after bladder removal surgery. It is the first FDA approval to use ctDNA results to guide therapy. It offers a more focused way to assess the risk of cancer recurrence, based on a blood‑based signal rather than imaging alone. Patients are selected for treatment based on serial ctDNA testing, which can begin at least six weeks after surgery and continue for up to a year. This approach helps target patients at a higher risk of recurrence while safely sparing lower-risk patients from unnecessary treatment and its side effects.
Why Was It Approved?
The FDA’s approval was based on data from a clinical study that showed that Tecentriq lowered the risk of disease recurrence or death and prolonged disease-free survival (DFS), compared with a placebo, in adults with MIBC who had their bladder and nearby lymph nodes removed and were positive for MRD on serial ctDNA blood tests.
What Do I Need to Know?
Tecentriq is given as an IV over 30 to 60 minutes. It is usually given every two, three, or four weeks for up to a year, unless the cancer returns or side effects are not tolerable. Tecentriq Hybreza is given as an under-the-skin shot every three weeks for up to a year, and the same stopping rules as Tecentriq apply. Your health care provider will choose the dosing schedule that fits your treatment plan. If you miss a dose, call your health care provider right away and reschedule it.
