AbbVie Announces FDA Accelerated Approval of EMRELIS™ for Advanced Non-Small Cell Lung Cancer Treatment
AbbVie Inc. has received FDA accelerated approval for EMRELIS™ (telisotuzumab vedotin-tllv) to treat adult patients with advanced non-small cell lung cancer (NSCLC) characterized by high c-Met protein overexpression. This marks a significant milestone as it is the first treatment for this specific NSCLC patient group. The approval follows the Breakthrough Therapy Designation based on Phase 2 study data, and a Phase 3 confirmatory study is currently underway. The FDA also approved the Roche VENTANA® MET (SP44) RxDx Assay as a companion diagnostic for patient eligibility.
NORTH CHICAGO, Ill., May 14, 2025 - AbbVie Inc. (NYSE: ABBV) has announced that EMRELIS™ (telisotuzumab vedotin-tllv) has received accelerated approval from the U.S. Food and Drug Administration (FDA) for treating adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression, who have previously undergone systemic therapy. This approval marks a significant milestone as EMRELIS is the first and only treatment available for this specific group of NSCLC patients, who often face limited treatment options and poor prognosis. The FDA had earlier granted EMRELIS Breakthrough Therapy Designation based on the Phase 2 LUMINOSITY study data. The drug is currently being further evaluated in a randomized Phase 3 confirmatory global study, TeliMET NSCLC-01, with patient enrollment underway. Additionally, the FDA has approved the Roche VENTANA® MET (SP44) RxDx Assay as the companion diagnostic to identify eligible patients for EMRELIS treatment.