FDA approves diagnostic tool for MET-targeted lung cancer therapy
Ella Day | May 19, 2025 | News story | Research and Development | FDA, Oncology, Roche, lung cancer, non-squamous non-small cell lung cancer
The US Food and Drug Administration (FDA) has approved Roche’s VENTANA MET (SP44) RxDx Assay as a diagnostic tool to identify non-squamous non-small cell lung cancer (NSQ-NSCLC) patients eligible for treatment with AbbVie’s targeted therapy Emrelis (telisotuzumab vedotin-tllv).
The assessment detects an overexpression of the MET protein, a predictive biomarker associated with tumour progression and therapeutic response in those with NSQ-NSCLC. Around 25% of patients with advanced NSCLC and wild-type epidermal growth factor receptor genes demonstrate high MET expression.
The FDA approval is based on data from AbbVie’s ongoing phase 2 LUMINOSITY study, which showed a 35% overall response rate and a median duration of response of 7.2 months in patients with high MET expression treated with Emrelis.
MET protein expression is determined by immunohistochemistry (IHC), with strong staining in at least 50% of tumour cells indicating overexpression. The assay is intended to guide clinicians in selecting MET-targeted therapies and offer a more personalised approach to treatment.
Globally, lung cancer remains the leading cause of cancer-related deaths and NSCLC accounts for approximately 85% of all lung cancer cases, with limited treatment options available at advanced stages.
The approval marks a step forward in integrating companion diagnostics into lung cancer care. “We can help provide timely, tailored treatment options that may improve patient outcomes and offer hope to those facing this challenging disease,” said Matt Sause, CEO of Roche Diagnostics.
Ella Day
19/5/25
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