FDA/CDC

FDA requires companion diagnostics for checkpoint inhibitors in urothelial cancer


 

The Food and Drug Administration has updated the prescribing information (PI) for pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. Two separate FDA-approved companion diagnostic tests are now required to determine PD-L1 levels in tumor tissue for those who are cisplatin-ineligible.

Pembrolizumab is now indicated for the treatment of patients who are not eligible for cisplatin-containing chemotherapy and whose tumors have a Combined Positive Score (CPS) for PD-L1 expression of greater than or equal to 10, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The FDA approved the Dako PD-L1 IHC 22C3 PharmDx Assay for determining PD-L1 expression, through staining in tumor and immune cells, before prescribing pembrolizumab.

Atezolizumab is now indicated for the treatment of patients who are not eligible for cisplatin-containing chemotherapy, and whose tumors show PD-L1 expression through stained tumor-infiltrating immune cells covering greater than or equal to 5% of the tumor area, or patients who are not eligible for any platinum-containing therapy regardless of level of tumor PD-L1 expression. The FDA approved the Ventana PD-L1 (SP142) Assay as a companion diagnostic test to determine PD L1 expression in immune cells before prescribing atezolizumab.

PI is updated for both drugs to require use of an FDA-approved test for selection of patients being treated in the first-line setting who are cisplatin-ineligible, but second-line indications in urothelial carcinoma for both drugs remain unchanged, according to an FDA statement.

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