Roche receives FDA approval of label expansion for Ventana PD-L1 (SP263) assay to identify patients with locally advanced and metastatic non-small cell lung cancer eligible for Libtayo

Roche

6 March 2023 - The Ventana PD-L1 (SP263) assay helps determine which patients with non-small cell lung cancer may be eligible for treatment with Libtayo monotherapy based on the results of the Phase 3 EMPOWER-Lung 1 trial.

Roche today announced that the US FDA has 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.

Read Roche press release

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Cancer , Outcome , US , Diagnostic agent