Medication Monitor

Generic Name (Trade Name—Company)
August 20, 2018

Pembrolizumab, atezolizumab

(Keytruda, Tecentriq—Merck, Genentech)
Updated prescribing info requires use of companion diagnostic test

FDA has updated the prescribing information for pembrolizumab and atezolizumab to require use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. Two different companion diagnostic tests were approved by FDA, one for use with pembrolizumab (Dako PD-L1 IHC 22C3 PharmDx Assay [Dako North America]) and one for use with atezolizumab (Ventana PD-L1 [SP142] Assay (Ventana Medical Systems)].

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.