U.S. FDA Approves EMRELIS™ (telisotuzumab vedotin-tllv) for Adults With Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC) With High c-Met Protein Overexpression

Core Insights - AbbVie announced the accelerated approval of EMRELIS™ (telisotuzumab vedotin-tllv) by the FDA for treating adult patients with advanced non-squamous non-small cell lung cancer (NSCLC) who have high c-Met protein overexpression and have received prior systemic therapy [1][2][3] - Lung cancer remains the leading cause of cancer-related deaths globally, with approximately 85% classified as NSCLC [2][3] - The approval is based on the overall response rate (ORR) and duration of response (DOR) from the Phase 2 LUMINOSITY study, which showed a 35% ORR and a median DOR of 7.2 months in patients with high c-Met overexpression [2][3] Company Overview - EMRELIS is AbbVie's first internally developed solid tumor medicine and represents a significant step in their commitment to developing cancer therapies [2][3] - The company is expanding its antibody-drug conjugate (ADC) portfolio to deliver targeted therapies to patients with difficult-to-treat tumors [2][3] - AbbVie is also focused on patient access, offering support programs to reduce out-of-pocket costs for eligible patients [6][21] Industry Context - The c-Met protein is overexpressed in approximately 25% of advanced EGFR wild type, non-squamous NSCLC patients, with about half of these patients having high c-Met overexpression [2][3] - There is a critical unmet need for targeted therapies in this patient population, as they often face poor prognosis and limited treatment options [2][3] - The FDA has also approved the Roche VENTANA® MET (SP44) RxDx Assay as a companion diagnostic to identify patients eligible for EMRELIS treatment [4][3]