AbbVie (ABBV) has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration, seeking accelerated approval for telisotuzumab vedotin (Teliso-V). This application targets adult patients who have previously undergone treatment for locally advanced or metastatic epidermal growth factor receptor (EGFR) wild-type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression.
The submission is supported by data gathered from the ongoing Phase 2 LUMINOSITY trial (Study M14-239), which aims to assess the safety and efficacy of Teliso-V in populations with c-Met overexpressing NSCLC.
In recognition of its potential, Teliso-V received Breakthrough Therapy Designation from the FDA in December 2021.