Roche Tissue Diagnostics Receives FDA Approval for Assay Label Expansion

Roche Tissue Diagnostics has announced that the U.S. Food and Drug Administration approved the VENTANA PD-L1 (SP263) Assay as a companion diagnostic to identify non-small cell lung cancer 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).  With this launch, more patients may have access to an additional immunotherapy option with Libtayo, potentially improving their treatment pathway and outcomes.

“Diagnostics, like our high medical value PD-L1 assay portfolio, enable personalized medicine to help improve patient outcomes,” said Jill German, head of Roche Tissue Diagnostics. “This approval helps physicians make more confident treatment decisions by identifying patients with tumors that may respond to the immunotherapy Libtayo.”

The 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.

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% of these cases are NSCLC. Roche has developed a leading, comprehensive and differentiated lung cancer immunohistochemical portfolio, with biomarkers that support multiple guidelines for the diagnosis and stratification of lung cancers.

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