FDA Approves Roche’s Assay for Libtayo in NSCLC

The FDA has approved Roche’s Ventana PD-L1 (SP263) assay as a companion diagnostic in identifying patients with non-small cell lung cancer (NSCLC) who are eligible for treatment with Regeneron’s Libtayo (cemiplimab) monotherapy.

The assay detects PD-L1 protein, which indicates the likelihood a patient could benefit from PD-L1/PD-1 immunotherapy drugs, including Libtayo.

Lung cancer is the leading cause of cancer death worldwide. Every year, more than 2.2 million people are diagnosed with lung cancer globally and up to 85 percent of these cases are NSCLC.