Roche Wins FDA Approval for Complementary PD-L1 (SP263) Biomarker Test for Urothelial Carcinoma

Swiss manufacturer Roche has received FDA approval of the VENTANA PD-L1 (SP263) assay as a complementary diagnostic to provide the programmed death ligand (PD-L1) status for patients with locally advanced or metastatic urothelial carcinoma who are being considered for treatment with the FDA-approved anti-PD-L1 immunotherapy Imfinzi.

The test evaluates patient PD-L1 status using both tumor and immune cell staining and scoring within the tumor microenvironment, providing clinicians with information for treatment decisions.

The assay detects the PD-L1 in a growing number of cancer indications.

The test is available in the US for use on the BenchMark ULTRA instrument. — Cynthia Jessup