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Roche Receives CE-Label Expansion for PD-L1 Assay in Lung Cancer Therapy

NEW YORK (360Dx) – Roche on Friday said that its PD-L1 assay has received CE-label expansion to identify untreated and previously treated patients with metastatic non-small cell lung cancer that are eligible for Merck's Keytruda (pembrolizumab) immunotherapy.

As a result, the Ventana PD-L1 (SP263) Assay — the only fully automated PD-L1 test for use with Keytruda to launch on Roche's BenchMark series of instruments — is available in countries accepting the CE mark, the firm said.

Roche first launched the Ventana PD-L1 (SP263) assay in September 2016 as a diagnostic test for previously treated metastatic NSCLC patients in countries accepting the CE mark. The new CE mark expands the assay's application to include patients being considered for Keytruda immunotherapy as the first line of treatment. Ann Costello, head of Roche tissue diagnostics, said in a statement that the assay "provides new insights into possible treatment options for this potentially deadly disease."

The firm said that it will continue to pursue regulatory approval for the assay in other cancer indications and in other geographies.

On Tuesday, Roche said that its PD-L1 assay had been approved by the US Food and Drug Administration as a complementary diagnostic for patients with locally advanced or metastatic urothelial carcinoma who are being considered for treatment with AstraZeneca's immunotherapy Imfinzi (durvalumab).

The FDA previously approved the PD-L1 test as a complementary diagnostic test for lung cancer and bladder cancer drug Tecentriqu.