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