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PD-L1 test required for immunotherapy in cisplatin-ineligible urothelial carcinoma patients
By: scienterrific | Last updated: 21 August 2018 | In: US FDA Onc\Haem Approvals, Genitourinary Cancer, Oncology, Immunotherapy
Article Keywords
urothelial carcinoma, atezolizumab, DAKO, cisplatin, SP142, FDA, Ventana, Keytruda, MSD, Genentech, Tecentriq, PD-L1, 22C3, pembrolizumab, CDx, Merck, CPS, Roche
On the 16th of August 2018, the FDA updated the prescribing information for pembrolizumab (Keytruda®, Merck) and atezolizumab (Tecentriq®, Roche/Genentech) and added the requirement for the use of an FDA-approved companion diagnostic test (CDx) to determine PD-L1 level expression in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma.
Pembrolizumab CDx
The FDA cleared the Dako PD-L1 IHC 22C3 PharmDx Assay® (Dako North America) to determine the combined positive score (CPS) by assessing the PD-L1 level expression in both tumour and immune cells for selection of cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma for pembrolizumab treatment./
Pembrolizumab is now indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-containing chemotherapy and a CPS ≥ 10, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 level expression.
Atezolizumab CDx
The FDA cleared the Ventana PD-L1 (SP142) Assay® (Ventana Medical Systems) to determine PD L1 expression in immune cells for selection of cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma for atezolizumab treatment.
Atezolizumab is now indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-containing chemotherapy, and with PD-L1 stained tumour-infiltrating immune cells covering ≥5% of the tumour area, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 level expression.
Disclaimer
This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).
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