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Monday, March 6, 2023

Roche receives FDA approval of label expansion for VENTANA PD-L1 (SP263) Assay

 

  • The VENTANA PD-L1 (SP263) Assay helps determine which patients with non-small cell lung cancer (NSCLC) may be eligible for treatment with Libtayo monotherapy1 based on the results of the Phase III EMPOWER-Lung 1 study.

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

  • PD-L1 testing provides clinicians with essential information that helps guide clinical decision making and improve patient outcomes.

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