Switzerland-based pharmaceutical company Roche (SIX:ROG)(OTCQX:RHHBY) announced on Monday that it has received approval from the US Food and Drug Administration (FDA) for the VENTANA PD-L1 (SP263) Assay as a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients eligible for treatment with Libtayo (cemiplimab), a PD-1 inhibitor therapy developed by Regeneron.

More than 60% of patients diagnosed with NSCLC are diagnosed at locally advanced or metastatic stage (Stage III-IV).2 With this launch, more patients may have access to an additional immunotherapy option with Libtayo, potentially improving their treatment pathway and outcomes.

The VENTANA PD-L1 (SP263) Assay is the only FDA approved product available with NSCLC indications for four different immunotherapy drugs, offering oncologists a broad range of treatment options for patients. Treating NSCLC as early as possible may improve patient outcomes.

The VENTANA PD-L1 (SP263) Assay, the only FDA approved product, is available with NSCLC indications for four different immunotherapy drugs, providing oncologists with a wide range of treatment options for patients. VENTANA PD-L1 (SP263) Assay is used to detect programmed death ligand-1 (PD-L1) protein in NSCLC patients. PD-L1 expression on tumour cells and immune cells has been shown in clinical studies to help predict the likelihood a patient may benefit from PD-L1/PD-1 immunotherapy drugs It is conducted on a BenchMark ULTRA instrument and is visualised utilising the OptiView DAB IHC Detection Kit.