May 16, 2025—Roche announced FDA approval for the Ventana MET (SP44) RxDx assay, the first companion diagnostic approved to aid in determining MET protein expression in patients with non-small cell lung cancer. These patients may now be eligible for treatment with AbbVie’s c-Met targeted therapy Emrelis (telisotuzumab vedotin-tllv).
Among advanced NSCLC patients with a normal epidermal growth factor receptor gene, around a quarter exhibit high levels of MET protein, making MET protein expression an important factor in determining treatment options for patients with this type of cancer. The Ventana MET (SP44) RxDx assay scores the MET protein based on how many tumor cells are stained and the intensity of the staining. The FDA’s approval is based on data from AbbVie’s phase two Luminosity clinical study, in which the test was used as the enrollment assay. The assay identified patients whose tumors were positive for MET protein overexpression, defined as ≥50 percent tumor cells demonstrating strong membrane MET staining.