Biotechnology company Roche Molecular Systems Inc (SIX: RO, ROG; OTCQX: RHHBY) disclosed on Monday that the U.S. Food and Drug Administration (FDA) has approved the VENTANA PD-L1 (SP263) Assay as a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients eligible for treatment with Regeneron's PD-1 inhibitor therapy Libtayo (cemiplimab).

The company said that this launch will offer more patients access to an additional immunotherapy option with Libtayo, potentially improving their treatment pathway and outcomes.

Roche stated that 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.

VENTANA PD-L1 (SP263) Assay is used to detect programmed death ligand-1 (PD-L1) protein in non-small cell lung carcinoma (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, the company added.