Roche announces that it has received FDA approval for the VENTANA MET (SP44) RxDx test as the first companion diagnostic to identify patients with non-squamous non-small cell lung cancer eligible for treatment with Emrelis.

The FDA's accelerated approval is based on data from the Phase 2 LUMINOSITY study, an ongoing study designed to characterize the efficacy and safety of Emrelis in patients with advanced NSCLC overexpressing the c-Met protein.

The study results showed that patients with high c-Met protein expression who received Emrelis had an overall response rate (ORR) and duration of response (DDR) of 35%, with a median of 7.2 months.

By identifying MET protein expression at the appropriate stage of the care pathway, we can help provide rapid and appropriate treatment options that may improve outcomes and bring hope to those facing this complex disease. Roche said.


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