On 27 September, AbbVie announced that it submitted a Biologics License Application (BLA) to the FDA for accelerated approval of telisotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression.
The BLA submission is supported by data from the Phase 2 LUMINOSITY trial (M14-239) which demonstrated a compelling overall response rate per independent central review (ICR) of 35 percent and 23 percent across c-Met High and c-Met Intermediate patients respectively.
If approved, Teliso-V will be the first-in-class therapy specifically for c-Met overexpressing NSCLC.