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FDA updates prescribing information for Keytruda, Tecentriq
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The FDA updated the prescribing information for pembrolizumab and atezolizumab to require use of an FDA-approved diagnostic test to determine PD-L1 levels among patients with locally advanced or metastatic urothelial cancer who are cisplatin ineligible.
The FDA approved two diagnostic tests, one for use with pembrolizumab (Keytruda, Merck) and one for use with atezolizumab (Tecentriq, Genentech) to aid in patient selection.
The first test, Dako PD-L1 IHC 22C3 PharmDx Assay (Dako North America), is indicated for use with pembrolizumab for the detection of PD-L1 expression. The test uses a combined positive score to assess PD-L1 staining in tumor and immune cells.
Pembrolizumab is indicated for patients who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 — as defined by a combined positive score of at least 10 — or for patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
Last month, the FDA approved the Ventana PD-L1 (SP142) Assay (Ventana Medical Systems) as a companion diagnostic test to determine PD-L1 expression in immune cells of patients with locally advanced or metastatic urothelial carcinoma who are cisplatin ineligible.
Atezolizumab is indicated for patients whose tumors express PD-L1, based on PD-L1-stained tumor-infiltrating immune cells covering at least 5% of the tumor area, or for patients not eligible for any platinum-containing therapy regardless of level of tumor PD-L1 expression.
The FDA updated the prescribing information for both drugs to require use of an FDA-approved test for selection of patients being treated for urothelial cancer in the first-line setting with either pembrolizumab or atezolizumab.
Prescribing information was not changed for second-line indications in urothelial carcinoma for both drugs.