Roche Assay Gets Additional Approval to Help Lung Cancer Patients

Roche has announced that the VENTANA PD-L1 (SP263) Assay is available in countries accepting the CE mark 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 non-small cell lung cancer are diagnosed at locally advanced or metastatic stage (Stage III-IV).With the launch of the VENTANA PD-L1 (SP263) Assay, more patients may have access to an additional immunotherapy option with Libtayo, potentially improving their treatment pathway and outcomes.

“With our companion diagnostics, we can help ensure each patient gets the most appropriate targeted treatment. This approval gives eligible advanced lung cancer patients access to the immunotherapy Libtayo as a first-line treatment,” said Jill German, head of Roche Tissue Diagnostics. “Our high medical value PD-L1 assay portfolio is continuing to help improve access to personalized medicine.”

The VENTANA PD-L1 (SP263) Assay is the only CE IVD product available with NSCLC indications for four different immunotherapy drugs, offering oncologists a broad range of treatment options for patients. Treating non-small cell lung cancer 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 non-small cell lung cancer.

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