Roche receives FDA approval for the VENTANA MET (SP44) RxDx Assay as the first companion diagnostic to identify non-small cell lung cancer patients eligible for treatment with EMRELIS
Roche announced that the U.S. Food and Drug Administration (FDA) has approved the VENTANA MET (SP44) RxDx Assay, the first companion diagnostic approved to aid in determining MET (also known as c-Met) protein expression in NSCLC patients.
These patients may now be eligible for treatment with AbbVie’s c-Met-targeted therapy EMRELIS™ (telisotuzumab vedotin-tllv), according to Roche.
The FDA accelerated approval is supported by data from the Phase 2 LUMINOSITY study, an ongoing study designed to characterize the efficacy and safety of EMRELIS in c-Met overexpressing advanced NSCLC populations. Findings from the study showed patients with c-Met protein high expression who received EMRELIS demonstrated 35% overall response rate (ORR) and duration of response (DoR) with a median of 7.2 months.
