The US Food and Drug Administration (FDA) has granted approval to Roche’s VENTANA MET (SP44) RxDx Assay to help determine the expression of mesenchymal-epithelial transition factor (MET or c-Met) protein in patients with non-squamous non-small cell lung cancer (NSQ-NSCLC).
This companion diagnostic assay is crucial for individuals to be considered for treatment with AbbVie鈥檚 Emrelis (telisotuzumab vedotin-tllv).
The agency鈥檚 decision is supported by data from the ongoing Phase II LUMINOSITY study of AbbVie aimed at characterising the safety and efficacy of Emrelis in subjects with c-Met overexpressing advanced NSQ-NSCLC.
In this study, the test was utilised as the enrolment assay.
Results from the LUMINOSITY study indicated that those with high c-Met protein expression who received the therapy achieved a 35% overall response rate (ORR) and a median duration of response (DoR) of 7.2 months.
Roche noted that introducing the first immunohistochemistry (IHC) MET companion diagnostic test is a key addition to its portfolio of IHC and in situ hybridisation (ISH) companion diagnostics.
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By GlobalDataThe assay operates by detecting the MET protein, with pathologists scoring the test based on the percentage of tumour cells stained and the staining intensity.
It claims to provide clinicians with essential information on the protein expression, guiding them to determine the potential benefit of c-Met-targeted therapy for patients, thus enabling a personalised treatment approach for NSQ-NSCLC.
Roche Diagnostics CEO Matt Sause said: 鈥淯nderstanding the molecular drivers in patients with NSCLC is critical for therapy selection.
鈥淏y identifying MET protein expression at the appropriate stage in the patient journey, we can help provide timely, tailored treatment options that may improve patient outcomes and offer hope to those facing this challenging disease.鈥�
Earlier this year, Roche received 510(k) clearance from the FDA for its Tina-quant Lipoprotein (a) Gen.2 Molarity assay.
