> ## 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 Seeks Accelerated OK for Lung Cancer Drug
- URL: https://www.fdaweb.com/abbvie-seeks-accelerated-ok-for-lung-cancer-drug/
- Published: 2023-11-30T12:00:00.000Z
- Updated: 2026-09-14T14:17:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155891

AbbVie says it will engage with FDA about filing for accelerated approval of telisotuzumab-vedotin (Teliso-V) in patients with c-Met protein overexpression, epidermal growth factor receptor wild type, advanced/metastatic nonsquamous non-small cell lung cancer (NSCLC). The decision to seek accelerated approval is based on just-announced topline results from the single-arm Phase 2 LUMINOSITY trial that demonstrated a “compelling overall response rate per independent central review (ICR) of 35% and 23% across c-Met High and c-Met Intermediate patients respectively,” the company says.

Teliso-V is described as an investigational first-in-class c-Met protein-directed antibody-drug conjugate targeting patients with c-Met overexpressing tumors. “C-Met is a receptor tyrosine kinase that is overexpressed in many solid tumors including NSCLC,” the company says.

Abbvie says that other endpoints demonstrated meaningful clinical outcomes including median duration of response of 9 months and 7.2 months, and a median overall survival of 14.6 months and 14.2 months in c-Met High and c-Met Intermediate patients respectively.

Regarding safety, the company says Teliso-V’s safety profile was consistent with previous findings and no new safety concerns were identified in the LUMINOSITY trial. “Adverse events with Teliso-V monotherapy were generally well managed and tolerated,” it says.