Roche Announces FDA Approval Of Label Expansion For VENTANA PD-L1 Assay

Roche (RHHBY) announced the FDA has approved the VENTANA PD-L1 Assay as a companion diagnostic to identify non-small cell lung cancer patients eligible for treatment with Libtayo, a PD-1 inhibitor therapy developed by Regeneron. The company noted that the VENTANA PD-L1 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.

Roche said the additional approval will allow more patients with locally advanced and metastatic NSCLC broader access to the immunotherapy Libtayo.

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