FDA Updates Urothelial Cancer Indications for 2 Immunotherapies
The US Food and Drug Administration (FDA) has updated the prescribing information of 2 cancer immunotherapies to include the requisite use of a companion diagnostic test to determine PD-L1 levels in the tumor tissue of patients with locally advanced or metastatic urothelial cancer.
This update to the prescribing information of pembrolizumab (Keytruda; Merck) and of atezolizumab (Tecentriq; Genentech) follows recent FDA approvals of companion diagnostic tests for each of these drugs.
The Dako PD-L1 IHC 22C3 PharmDx Assay
On August 16, 2018, the FDA approved Dako PD-L1 IHC 22C3 PharmDx Assay (Dako North America) as a companion diagnostic tool to select patients with locally advanced or metastatic cancer who are ineligible for treatment with cisplatin but candidates for pembrolizumab therapy. The 22C3 test uses a combined positive score of PD-L1 staining in tumor and immune cell to
determine PD-L1 expression levels in these patients.
The prescribing information for pembrolizumab has been updated to reflect that the drug is indicated for the first-line treatment of cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer and tumors expressing PD-L1 levels determined via an FDA-approved test, and patients ineligible for any platinum-containing chemotherapy, regardless of PD-L1 status.
The Ventana PD-L1 (SP142) Assay
On July 2, 2018, the FDA approved the Ventana PD-L1 (SP142) Assay (Ventana Medical Systems) as a companion diagnostic tool to select patients with locally advanced or metastatic urothelial cancer who are ineligible for treatment with cisplatin but candidates for atezolizumab therapy.
The prescribing information for atezolizumab has been updated to reflect that the drug is indicated for the first-line treatment of cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer and tumors expressing PD-L1 levels determined via an FDA-approved test, and patients who are ineligible for any platinum-containing therapy, regardless of PD-L1 status.
Of note, the prescribing information updates for pembrolizumab and atezolizumab only apply to patients receiving first-line treatment; neither drug has had changes made to their respective second-line indications for urothelial cancer.
—Janelle Bradley
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