WASHINGTON (dpa-AFX) - AbbVie (ABBV) announced submission of a Biologics License Application or BLA to the U.S. Food and Drug Administration for accelerated approval of telisotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor or EGFR wild type, nonsquamous non-small cell lung cancer or NSCLC with c-Met protein overexpression.
The BLA submission is supported by data from Phase 2 LUMINOSITY trial (Study M14-239), an ongoing study designed to characterize the safety and efficacy of Teliso-V in c-Met overexpressing NSCLC populations.
Teliso-V was granted Breakthrough Therapy Designation by the FDA in December 2021.
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