By Fineline Cube 
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to AbbVie’s (NYSE: ABBV) Emrelis (telisotuzumab vedotin) for the treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) exhibiting high c-MET protein overexpression. This decision further expands the treatment landscape for patients with this aggressive form of lung cancer.
Emrelis: Mechanism and Previous Approval
Emrelis is a c-MET-directed antibody-drug conjugate (ADC) that combines a monoclonal antibody with a microtubule inhibitor. It initially received U.S. approval for NSCLC in January 2022. The drug works by targeting cancer cells that overexpress the c-MET protein, delivering the cytotoxic agent directly to the tumor site.
Clinical Trial Data
The approval is supported by data from the Phase II LUMINOSITY trial, which evaluated Emrelis in patients with c-MET-overexpressing NSCLC. The Independent Center Review (ICR) analysis results showed a significant difference in overall response rate (ORR) between patients with high c-Met expression (35%) versus moderate c-Met expression (23%). Additionally, the median duration of response (DOR) was 9 months for patients with high c-Met expression compared to 7.2 months for those with moderate expression. The median overall survival (OS) was also slightly improved at 14.6 months versus 14.2 months.-Fineline Info & Tech