FDA Updates Prescribing Information for Pembrolizumab and Atezolizumab

FDA requires use of an FDA-approved test to determine PD-L1 for selection of patients with locally advanced or metastatic urothelial cancer for first-line treatment in cisplatin-ineligible setting
05 Sep 2018

On 16 August 2018, the US 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 PD-L1 levels in tumour tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. FDA approved two different companion diagnostic tests, one for use with Keytruda and one for use with Tecentriq.

On 16 August 2018, the FDA approved the Dako PD-L1 IHC 22C3 PharmDx Assay (Dako North America, Inc.) as a companion diagnostic to select patients with locally advanced or metastatic urothelial carcinoma who are cisplatin-ineligible for treatment with Keytruda. The 22C3 assay determines PD-L1 expression by using a combined positive score (CPS) assessing PD-L1 staining in tumour and immune cells.

The updated indication for Keytruda is: Keytruda is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumours 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.

On 2 July 2018, the FDA approved the Ventana PD-L1 (SP142) Assay® (Ventana Medical Systems, Inc.) as a companion diagnostic test to select patients with locally advanced or metastatic urothelial carcinoma who are cisplatin-ineligible for treatment with Tecentriq. The SP142 assay determines PD L1 expression in immune cells.

The updated indication for Tecentriq is: Tecentriq is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:

  • Are not eligible for cisplatin-containing chemotherapy, and whose tumours express PD-L1 (PD-L1 stained tumour-infiltrating immune cells [IC] covering ≥5% of the tumour area), as determined by an FDA-approved test, or
  • Are not eligible for any platinum-containing therapy regardless of level of tumour 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 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.

Prescribing information for Keytruda is available here and for Tecentriq here.

Last update: 05 Sep 2018

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings