Immunotherapy in Bladder Cancer: FDA Updates Labels, Approves Diagnostic Tools

The Food and Drug Administration (FDA) updated the prescribing information for two immunotherapy agents — Keytruda (pembrolizumab) and Tecentriq (atezolizumab) – approved to treat patients with locally advanced or metastatic bladder cancer who are not eligible for cisplatin-based therapy.

Physicians must now use an FDA-approved companion diagnostic tool to test PD-L1 levels in patients’ tumor tissue before prescribing Keytruda or Tecentriq, the agency said. Two such tools were granted FDA approval this summer: the Dako PD-L1 IHC 22C3 PharmDx Assay and the Ventana PD-L1 (SP142) Assay.

PD-L1 is a protein that interacts with another protein, PD-1, and together they tell a person’s immune system not to attack cancer cells. Keytruda and Tecentriq both inhibit PD-L1’s activity, signaling to the immune system that cancer cells are something foreign and dangerous that the immune system should attack.

The Dako PD-L1 IHC 22C3 PharmDx Assay was approved as a diagnostic tool that will select patients with locally advanced or metastatic bladder cancer who are cisplatin-ineligible for treatment with Keytruda. Now using this tool, this group of patients will be deemed eligible for Keytruda if they have a combined positive score (CPS) PD-L1 status of 10 or higher. The drug is also approved for patients with bladder cancer who are not eligible for platinum-containing chemotherapy, regardless of PD-L1 status.

To be prescribed Tecentriq, cisplatin-ineligible patients with advanced or metastatic disease must undergo the Ventana PD-L1 (SP142) Assay, which determines PD-L1 expression on immune cells.

Now, Tecentriq is indicated to treat patients with locally advanced or metastatic bladder cancer who are not eligible for cisplatin-containing chemo and whose tumors express a 5 percent or higher PD-L1 staining, as determined by the new test or for patients who are not eligible for any platinum-containing therapy, regardless of their PD-L1 status.

Back in June, the FDA updated the labels for Keytruda and Tecentriq for existing frontline approvals for platinum-ineligible patients with bladder cancer.