AbbVie Announces FDA Accelerated Approval of EMRELIS™ for Advanced Non-Small Cell Lung Cancer Treatment

Reuters
05-15
AbbVie Announces FDA Accelerated Approval of EMRELIS™ for Advanced Non-Small Cell Lung Cancer Treatment

NORTH CHICAGO, Ill., May 14, 2025 - AbbVie Inc. $(ABBV)$ 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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. AbbVie Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: CG68332) on May 14, 2025, and is solely responsible for the information contained therein.

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