Pembrolizumab and atezolizumab USPIs updated by FDA

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PD-L1 test required for immunotherapy in cisplatin-ineligible urothelial carcinoma patients

By: News Feed | Last updated: 21st August 2018 | In: Genitourinary Cancer, ImmunoOncology, Immunotherapy, Oncology, US FDA Onc\Haem Approvals

Article Keywords

22C3, atezolizumab, CDx, cisplatin, CPS, DAKO, FDA, Genentech, Keytruda, Merck, MSD, PD-L1, pembrolizumab, Roche, SP142, Tecentriq, urothelial carcinoma, Ventana

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.

Keytruda® Prescribing Information

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.

Tecentriq® Prescribing Information

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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Approved Immune-Checkpoint Inhibitors and Immunotherapies says:

20th November 2018 at 10:22 AM

[…] Ineligible for cisplatin-based chemotherapy and a CPS (combined positive score: PD-L1 level expression on tumour and immune cells)≥10, or; […]

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