> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Abbvie Gets Breakthrough Status on Lung Cancer Drug
- URL: https://www.fdaweb.com/abbvie-gets-breakthrough-status-on-lung-cancer-drug/
- Published: 2022-01-04T12:00:00.000Z
- Updated: 2026-09-14T17:27:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150862

FDA has granted AbbVie a breakthrough therapy designation for telisotuzumab vedotin (Teliso-V) and its use in treating patients with advanced/metastatic epidermal growth factor receptor wild type, nonsquamous non-small cell lung cancer (NSCLC) with high levels of c-Met overexpression whose disease has progressed on or after platinum-based therapy. The designation is based on data from LUMINOSITY (Study M14-239), an ongoing Phase 2 study designed to identify the target NSCLC populations that overexpress c-Met best suited for Teliso-V monotherapy in the second line or third line setting, according to the company. The primary endpoint is overall response rate (ORR) in patients after 12 weeks of follow-up. In a previously reported interim analysis, ORR was 53.8% in the c-Met high group and 25.0% in the c-Met intermediate group. the company says. Teliso-V ia described as an investigational antibody-drug conjugate targeting c-Met, a receptor tyrosine kinase that is overexpressed in tumors including NSCLC.