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# AbbVie BLA for Teliso-V in Lung Cancer
- URL: https://www.fdaweb.com/abbvie-bla-for-teliso-v-in-lung-cancer/
- Published: 2024-09-27T12:00:00.000Z
- Updated: 2026-09-14T14:42:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157877

AbbVie has submitted a BLA seeking accelerated approval for Teliso-V (telisotuzumab vedotin) and its use 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 c-Met protein is a receptor tyrosine kinase found to be overexpressed in approximately 25% of advanced EGFR wild type, nonsquamous NSCLC patients and is associated with a poor prognosis,” the company says.

The submission is based on data from the Phase 2 LUMINOSITY trial ([Study M14-239](https://c212.net/c/link/?t=0&l=en&o=4264002-1&h=3576104919&u=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03539536&a=Study+M14-239&ref=fdaweb.com)) and the endpoints include overall response rate (ORR), duration of response, disease control rate and progression-free survival. For example, the results showed a “compelling” ORR of 35% and 23% across c-Met High and c-Met intermediate patients, respectively, the company says.

Teliso-V is described as a c-Met protein-directed antibody-drug conjugate designed to target c-Met overexpressing tumors.