AbbVie submits BLA for antibody-drug conjugate Teliso-V for NSCLC
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- 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.