艾伯维提交了针对非小细胞肺癌的抗体-药物结合物Teliso-V的BLA

2024-09-28 00:42

AbbVie (NYSE:ABBV) has submitted an NDA to the U.S. FDA for its antibody-drug conjugate telisotuzumab vedotin (Teliso-V) for previously treated non-small cell lung cancer.
Specifically, the application is seeking approval in patients with locally advanced or metastatic NSCLC that is epidermal growth factor receptor (EGFR) wild type with c-Met protein overexpression.
AbbVie noted that c-Met protein is a receptor tyrosine kinase that is overexpressed in ~25% of advanced EGFR wild type NSCLC.
The application is supported by data from the phase 2 LUMINOSITY trial. Patient reported outcome data was presented at the recent European Society of Medical Oncology Congress. Positive topline data was released in November 2023.
Also, trends in patient reported outcomes from LUMINOSITY are being evaluated in the Phase 3 TeliMET NSCLC-01 trial, which is ongoing.
Teliso-V, a first-in-class, c-Met protein directed ADC, has Breakthrough Therapy Designation from the FDA. AbbVie has previously stated it expects a decision from the agency in 2025.

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