FDA Updates Prescribing Information for Pembrolizumab and Atezolizumab in Urothelial Carcinoma

On August 16, 2018, the U.S. Food and Drug Administration (FDA) updated the prescribing information for pembrolizumab (Keytruda) and atezolizumab (Tecentriq) to require the use of an FDA-approved companion diagnostic test to determine programmed cell death ligand 1 (PD-L1) levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin therapy. The FDA approved two different companion diagnostic tests—one for use with each agent—as described below.

Pembrolizumab Test

On August 16, 2018, the FDA approved the Dako PD-L1 IHC 22C3 PharmDx Assay as a companion diagnostic to select patients with locally advanced or metastatic urothelial carcinoma who are cisplatin-ineligible for treatment with pembrolizumab. The 22C3 assay determines PD-L1 expression by using a combined positive score (CPS) assessing PD-L1 staining in tumor and immune cells. The updated indication for pembrolizumab is described in the prescribing information as follows:

Pembrolizumab is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS ≥ 10) as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

Atezolizumab Test

On July 2, 2018, the FDA approved the Ventana PD-L1 (SP142) Assay as a companion diagnostic test to select patients with locally advanced or metastatic urothelial carcinoma who are cisplatin-ineligible for treatment with atezolizumab. The SP142 assay determines PD-L1 expression in immune cells. The updated indication for atezolizumab is described in the prescribing information as follows:

Atezolizumab is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:

  • Are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (PD-L1–stained tumor-infiltrating immune cells covering ≥ 5% of the tumor area), as determined by an FDA-approved test, or
  • Are 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 the selection of patients being treated in the first-line setting who are cisplatin-ineligible. The second-line indications in urothelial carcinoma for both drugs remain unchanged. The tests used in the trials to determine PD-L1 expression are listed in Section 14 of each drug label.

View the updated label information at https://labels.fda.gov/.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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